The effect of vitamin B5 administration compared to placebo on stress; depression; Anxiety, oxidative stress level and serum cortisol level in type 2 diabetes patients
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Recruitment centers
#1
Name of recruitment center - English: Imam Ali Clinic/Shahrekord University of Medical Sciences
Name of recruitment center - Persian: کلینیک امام علی/ دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: گلشن تقی پور بروجنی
Full name of responsible person - Persian: Golshan Taghipour Borojni
Street address - English: Shahrekord, Shariati Blvd., Imam Ali (A.S.) Specialized Clinic
Street address - Persian: شهرکرد، بلوار شریعتی، کلینیک تخصصی امام علی(ع)
City - English: shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8816758915
Phone: +98 38 3224 2696
Fax:
Email: golshan.taghipour@gmail.com
Web page address: https://imamaliclinic.skums.ac.ir/#
Name of recruitment center - English: Imam Ali Clinic; Shahrekord University of Medical Sciences
Name of recruitment center - Persian: کلینیک امام علی؛ دانشگاه علوم پزشکی شهرکرد
Full name of responsible person - English: Reihaneh Sadeghian
Full name of responsible person - Persian: ریحانه صادقیان
Street address - English: Imam Ali (A.S.) Specialized Clinic; Shariati Blvd.; Shahrekord
Street address - Persian: شهرکرد، بلوار شریعتی، کلینیک تخصصی امام علی(ع)
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8816758915
Phone: +98 915 205 8035
Fax:
Email: reihaneh.sadeghian5@gmail.com
Web page address: https://orcid.org/0000-0002-0777-002X
Name of recruitment center - English: Imam Ali Clinic/; Shahrekord University of Medical Sciences Name of recruitment center - Persian: کلینیک امام علی/؛ دانشگاه علوم پزشکی شهرکرد Full name of responsible person - English: گلشن تقی پور بروجنیReihaneh Sadeghian Full name of responsible person - Persian: Golshan Taghipour Borojniریحانه صادقیان Street address - English: Shahrekord, Shariati Blvd., Imam Ali (A.S.) Specialized Clinic; Shariati Blvd.; Shahrekord Street address - Persian: شهرکرد، بلوار شریعتی، کلینیک تخصصی امام علی(ع) City - English: shahrekordShahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8816758915 Phone: +98 38 3224 2696915 205 8035 Fax: Email: golshan.taghipourreihaneh.sadeghian5@gmail.com Web page address: https://imamaliclinic.skums.ac.irorcid.org/# 0000-0002-0777-002X
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Golshan Taghipour
Full name of responsible person - Persian: گلشن تقی پور
Street address - English: Shahrekord, Hajar Hospital
Street address - Persian: شهرکرد، بیمارستان هاجر
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8816854633
Phone: +98 913 184 2580
Fax:
Email: golshan.taghipour@gmail.com
Web page address: https://imamaliclinic.skums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Golshan Taghipour
Full name of responsible person - Persian: گلشن تقی پور
Street address - English: Clinic No. 1 of Hajar Hospital; Parastar street; Shahrekord
Street address - Persian: شهرکرد، خیابان پرستار، کلینیک شماره ۱ بیمارستان هاجر
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Country: Iran (Islamic Republic of)
Postal code: 8816854633
Phone: +98 913 184 2580
Fax:
Email: golshan.taghipour@gmail.com
Web page address: https://imamaliclinic.skums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Golshan Taghipour Full name of responsible person - Persian: گلشن تقی پور Street address - English: Shahrekord,Clinic No. 1 of Hajar Hospital; Parastar street; Shahrekord Street address - Persian: شهرکرد، خیابان پرستار، کلینیک شماره ۱ بیمارستان هاجر City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Country: Iran (Islamic Republic of) Postal code: 8816854633 Phone: +98 913 184 2580 Fax: Email: golshan.taghipour@gmail.com Web page address: https://imamaliclinic.skums.ac.ir/
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reihaneh Sadeghian
Full name of responsible person - Persian: ریحانه صادقیان
Position - English: Assistant Professor of neurophysiology
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 63
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street
Street address - Persian: خیابان کاشانی، ستاد مرکزی دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3334 9509
Mobile: +98 915 205 8035
Fax:
Email: reihaneh.sadeghian5@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Reihaneh Sadeghian
Full name of responsible person - Persian: ریحانه صادقیان
Position - English: Assistant Professor of physiology
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street
Street address - Persian: خیابان کاشانی، ستاد مرکزی دانشگاه علوم پزشکی شهرکرد
City - English: Shahrekord
City - Persian: شهرکرد
Province: Chahar-Mahal-va-Bakhtiari
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8815713471
Phone: +98 38 3334 9509
Mobile: +98 915 205 8035
Fax:
Email: reihaneh.sadeghian5@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Reihaneh Sadeghian Full name of responsible person - Persian: ریحانه صادقیان Position - English: Assistant Professor of neurophysiologyphysiology Position - Persian: استادیار Latest degree: phd Area of specialty/work: 6369 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street Street address - Persian: خیابان کاشانی، ستاد مرکزی دانشگاه علوم پزشکی شهرکرد City - English: Shahrekord City - Persian: شهرکرد Province: Chahar-Mahal-va-Bakhtiari Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8815713471 Phone: +98 38 3334 9509 Mobile: +98 915 205 8035 Fax: Email: reihaneh.sadeghian5@gmail.com Web page address:
Trial results
No
Yes
1
empty
2024-09-21, 1403/06/31
2024-09-21 15:13:55
Variable
Group
Control.N=19
intervention.N=19
p-value
Frequency (Percentage)
Gender
male
9(47.4)
7(36.8)
0.511
female
10(52.6)
12(63.2)
Marital status
Single
0(0)
0(0)
1.000
marreid
19(100)
(100)19
Blood sugar lowering drug
Metformin
11(57.9)
15(78.9)
0.163
Insulin
8(42.1)
4(21.1)
Family History
1st degree family
0(0.0)
0(0.0)
2nd degree family
(100)19
(100)19
1.000
No record
0(0.0)
0(0.0)
Level of Education
Illiterate
7(36.8)
6(31.6)
0.723
Primary education
7(36.8)
9(47.4)
Secondary education
4(21.1)
2(10.5)
Bachelor 's degree and above
1(5.3)
2(10.5)
Average ± Standard Deviation
Age (years)
56.94 ±9.11
55.21±3.45
0.445
Body mass index (BMI)
27.47 ±2.58
29.35±1.63
0.076
Fasting blood sugar (FBS)
142.89±42.58
154.26 ±26.97
0.333
B5 Vitamin nutritional status
97.5±30.1
91.4±56.0
0.095
Trait anxiety
48.21±5.88
48.53±6.23
0.873
Situational anxiety
48.47±3.38
49.37±5.13
0.530
General health
18.32±1.11
18.37±1.16
0.887
Physical performance
23.00±2.19
24.84±2.34
0.017
Limitation due to physical health condition
15.11±2.26
14.21±2.68
0.273
Limitation caused by emotional health status
11.42±2.19
11.16±3.24
0.771
Energy and vitality
10.79±1.51
10.74±1.51
0.911
Emotional health
16.37±1.74
17.05±2.72
0.361
Social performance
6.05±0.85
6.21±1.27
0.655
Pain
6.21±1.51
5.95±1.99
0.649
Cortisol levels
6.19±1.96
8.37 ±3.37
0.020
Middle (first and third quadrants)
Depression, Anxiety, Stress (DASS-21)
16 (10-30)
14 (8-24)
0.704
Beck Anxiety Inventory (BAI)
9 (3-11)
8 (4-15)
0.520
Variable
Group
Control.N=19
intervention.N=19
p-value
Frequency (Percentage)
Gender
male
9(47.4)
7(36.8)
0.511
female
10(52.6)
12(63.2)
Marital status
Single
0(0)
0(0)
1.000
marreid
19(100)
(100)19
Blood sugar lowering drug
Metformin
11(57.9)
15(78.9)
0.163
Insulin
8(42.1)
4(21.1)
Family History
1st degree family
0(0.0)
0(0.0)
2nd degree family
(100)19
(100)19
1.000
No record
0(0.0)
0(0.0)
Level of Education
Illiterate
7(36.8)
6(31.6)
0.723
Primary education
7(36.8)
9(47.4)
Secondary education
4(21.1)
2(10.5)
Bachelor 's degree and above
1(5.3)
2(10.5)
Average ± Standard Deviation
Age (years)
56.94 ±9.11
55.21±3.45
0.445
Body mass index (BMI)
27.47 ±2.58
29.35±1.63
0.076
Fasting blood sugar (FBS)
142.89±42.58
154.26 ±26.97
0.333
B5 Vitamin nutritional status
97.5±30.1
91.4±56.0
0.095
Trait anxiety
48.21±5.88
48.53±6.23
0.873
Situational anxiety
48.47±3.38
49.37±5.13
0.530
General health
18.32±1.11
18.37±1.16
0.887
Physical performance
23.00±2.19
24.84±2.34
0.017
Limitation due to physical health condition
15.11±2.26
14.21±2.68
0.273
Limitation caused by emotional health status
11.42±2.19
11.16±3.24
0.771
Energy and vitality
10.79±1.51
10.74±1.51
0.911
Emotional health
16.37±1.74
17.05±2.72
0.361
Social performance
6.05±0.85
6.21±1.27
0.655
Pain
6.21±1.51
5.95±1.99
0.649
Cortisol levels
6.19±1.96
8.37 ±3.37
0.020
Middle (first and third quadrants)
Depression, Anxiety, Stress (DASS-21)
16 (10-30)
14 (8-24)
0.704
Beck Anxiety Inventory (BAI)
9 (3-11)
8 (4-15)
0.520
متغیر
گروه
Pمقدار
کنترل.N=19
مداخله.N=19
فراوانی(درصد)
جنسیت
مرد
(47.4)9
(36.8)7
0.511
زن
(52.6)10
(63.2)12
وضعیت تاهل
مجرد
(0)0
(0)0
1.000
متاهل
(100)19
(100)19
داروی مصرفی
متفورمین
(57.9)11
(78.9)15
0.163
انسولین
(42.1)8
(21.1)4
سابقه فامیلی
خانواده درجه1
(0.0)0
(0.0)0
1.000
خانواده درجه 2
(100)19
(100)19
بدون سابقه
(0/0)0
(0/0)0
سطح تحصیلات
بی سواد
(36.8)7
(31.6)6
0.723
ابتدایی
(36.8)7
(47.4)9
سیکل
(21.1)4
(10.5)2
لیسانس وبالاتر
(5.3)1
(10.5)2
میانگین±انحراف استاندارد
سن(سال)
56.94±9.11
55.21±3.45
0.445
شاخص توده بدنی(BMI)
27.47±2.58
29.35±1.63
0.076
قندخون ناشتا(FBS)
142.89±42.58
154.26±26.97
0.333
وضعیت ویتامینB5تغذیه ایی
97.5±30.1
91.4±56.0
0.095
اضطراب صفتی
48.21±5.88
48.53±6.23
0.873
اضطراب موقعیتی
48.47±3.38
49.37±5.13
0.530
سلامت عمومی
18.32±1.11
18.37±1.16
0.887
عملکردجسمانی
23.00±2.19
24.84±2.34
0.017
محدودیت ناشی ازوضعیت سلامت جسمانی
15.11±2.26
14.21±2.68
0.273
محدودیت ناشی ازوضعیت سلامت هیجانی
11.42±2.19
11.16±3.24
0.771
انرژی ونشاط
10.79±1.51
10.74±1.51
0.911
سلامت عاطفی
16.37±1.74
17.05±2.72
0.361
عملکرداجتماعی
6.05±0.85
6.21±1.27
0.655
درد
6.21±1.51
5.95±1.99
0.649
سطح کورتیزول
6.19±1.96
8.37±3.37
0.020
میانه(چارک اول وسوم)
نمره افسردگی(Dass-21)
(10-30)16
(8-24)14
0.704
نمره اضطراب(Beck)
(3-11)9
(4-15)8
0.520
متغیر
گروه
Pمقدار
کنترل.N=19
مداخله.N=19
فراوانی(درصد)
جنسیت
مرد
(47.4)9
(36.8)7
0.511
زن
(52.6)10
(63.2)12
وضعیت تاهل
مجرد
(0)0
(0)0
1.000
متاهل
(100)19
(100)19
داروی مصرفی
متفورمین
(57.9)11
(78.9)15
0.163
انسولین
(42.1)8
(21.1)4
سابقه فامیلی
خانواده درجه1
(0.0)0
(0.0)0
1.000
خانواده درجه 2
(100)19
(100)19
بدون سابقه
(0/0)0
(0/0)0
سطح تحصیلات
بی سواد
(36.8)7
(31.6)6
0.723
ابتدایی
(36.8)7
(47.4)9
سیکل
(21.1)4
(10.5)2
لیسانس وبالاتر
(5.3)1
(10.5)2
میانگین±انحراف استاندارد
سن(سال)
56.94±9.11
55.21±3.45
0.445
شاخص توده بدنی(BMI)
27.47±2.58
29.35±1.63
0.076
قندخون ناشتا(FBS)
142.89±42.58
154.26±26.97
0.333
وضعیت ویتامینB5تغذیه ایی
97.5±30.1
91.4±56.0
0.095
اضطراب صفتی
48.21±5.88
48.53±6.23
0.873
اضطراب موقعیتی
48.47±3.38
49.37±5.13
0.530
سلامت عمومی
18.32±1.11
18.37±1.16
0.887
عملکردجسمانی
23.00±2.19
24.84±2.34
0.017
محدودیت ناشی ازوضعیت سلامت جسمانی
15.11±2.26
14.21±2.68
0.273
محدودیت ناشی ازوضعیت سلامت هیجانی
11.42±2.19
11.16±3.24
0.771
انرژی ونشاط
10.79±1.51
10.74±1.51
0.911
سلامت عاطفی
16.37±1.74
17.05±2.72
0.361
عملکرداجتماعی
6.05±0.85
6.21±1.27
0.655
درد
6.21±1.51
5.95±1.99
0.649
سطح کورتیزول
6.19±1.96
8.37±3.37
0.020
میانه(چارک اول وسوم)
نمره افسردگی(Dass-21)
(10-30)16
(8-24)14
0.704
نمره اضطراب(Beck)
(3-11)9
(4-15)8
0.520
Reihaneh Sadeghian
Supervisor
Seyed Hasan Hosseini
MD student
Golshan Taghipour
Supervisor
Motahareh Sadat Mirhaj
Advisor
Ammar Salehi
Advisor
Mahboobe Taghipour
Scientific Co-Workers
Alireza Amirbeigi
Scientific Co-Workers
Reihaneh Sadeghian
Supervisor
Seyed Hasan Hosseini
MD student
Golshan Taghipour
Supervisor
Motahareh Sadat Mirhaj
Advisor
Ammar Salehi
Advisor
Mahboobe Taghipour
Scientific Co-Workers
Alireza Amirbeigi
Scientific Co-Workers
ریحانه صادقیان
استاد راهنما
سیدحسن حسینی
دانشجوی پزشکی
گلشن تقی پور
استاد راهنما
مطهره سادات میرحاج
استاد مشاور
عمار صالحی
استاد مشاور
محبوبه تقی پور
همکارعلمی
علیرضا امیریگی
همکار علمی
ریحانه صادقیان
استاد راهنما
سیدحسن حسینی
دانشجوی پزشکی
گلشن تقی پور
استاد راهنما
مطهره سادات میرحاج
استاد مشاور
عمار صالحی
استاد مشاور
محبوبه تقی پور
همکارعلمی
علیرضا امیریگی
همکار علمی
control
intervention
difference
variables
before
after
p-value
before
after
p-value
control
internention
p-value
Body mass index (BMI)
27.47±2.58
27.51±2.57
0.217
29.35±1.63
29.40±1.57
0.488
0.04±0.13
0.05±0.23
0.844
Fasting blood sugar (FBS)
142.89±42.58
142±41.70
0.601
154.26±26.97
148.42±12.44
0.251
-0.89±7.33
-5.84±21.47
0.352
B5 Vitamin nutritional status
5.97±1.30
5.83±1.29
0.164
4.91±0.56
4.97±0.51
0.202
0.14±0.41
0.06±0.19
0.073
Trait anxiety
48.21±5.88
49.11±5.85
0.056
48.53±6.23
46.89±6.80
0.047
0.89±1.91
-1.63±3.74
0.014
Situational anxiety
48.47±3.39
48.95±3.70
0.432
49.37±5.13
46.42±5.26
0.002
0.47±2.57
-2.95±3.50
0.002
General health
18.32±1.11
18.37±1.42
0.790
18.37±1.16
18.05±1.68
0.187
0.05±0.85
-0.32±1.00
0.229
Physical performance
23.00±2.19
23.72±2.22
0.007
24.84±2.34
25.68±3.00
0.145
0.42±0.61
0.84±2.41
0.469
Limitation due to physical health condition
15.11±2.26
14.68±2.31
0.002
14.21±2.68
14.53±3.15
0.055
-0.42±0.51
0.32±0.67
0.001
Limitation caused by emotional health status
11.42±2.19
11.68±2.45
0.056
11.16±3.24
12.42±2.83
<0.001
0.26±0.56
1.26±1.15
0.002
Energy and vitality
10.79±1.151
11.16±1.64
0.005
10.47±1.37
11.00±1.89
0.471
0.37±0.50
0.26±1.56
0.782
Emotional health
16.37±1.74
16.37±1.74
1.000
17.05±2.72
17.58±3.08
0.249
0.00±0.82
0.53±1.93
0.280
Social performance
6.05±0.85
6.21±1.51
0.083
6.21±1.27
6.47±1.26
0.056
0.16±0.37
0.26±0.56
0.501
Pain
6.21±1.51
5.79±1.44
0.002
5.95±1.99
5.53±2.41
0.119
-0.42±0.51
-0.42±1.12
1.000
Cortisol levels
6.19±1.96
6.37±2.02
0.211
8.37±3.37
6.12±2.57
0.042
0.18±0.60
-2.25±4.48
0.031
Depression, Anxiety, Stress (DASS-21)
16 (10-30)
16 (10-28)
0.042
14 (8-24)
7 (6-13)
0.003
0 (-2-0)
-5 (-10-1)
<0.001
Beck Anxiety Inventory (BAI)
9 (3-11)
7 (3-10)
0.047
8 (4-15)
6 (4-13)
<0.001
-1 (-2-0)
-1 (-4-0)
0.235
control
intervention
difference
variables
before
after
p-value
before
after
p-value
control
internention
p-value
Body mass index (BMI)
27.47±2.58
27.51±2.57
0.217
29.35±1.63
29.40±1.57
0.488
0.04±0.13
0.05±0.23
0.844
Fasting blood sugar (FBS)
142.89±42.58
142±41.70
0.601
154.26±26.97
148.42±12.44
0.251
-0.89±7.33
-5.84±21.47
0.352
B5 Vitamin nutritional status
5.97±1.30
5.83±1.29
0.164
4.91±0.56
4.97±0.51
0.202
0.14±0.41
0.06±0.19
0.073
Trait anxiety
48.21±5.88
49.11±5.85
0.056
48.53±6.23
46.89±6.80
0.047
0.89±1.91
-1.63±3.74
0.014
Situational anxiety
48.47±3.39
48.95±3.70
0.432
49.37±5.13
46.42±5.26
0.002
0.47±2.57
-2.95±3.50
0.002
General health
18.32±1.11
18.37±1.42
0.790
18.37±1.16
18.05±1.68
0.187
0.05±0.85
-0.32±1.00
0.229
Physical performance
23.00±2.19
23.72±2.22
0.007
24.84±2.34
25.68±3.00
0.145
0.42±0.61
0.84±2.41
0.469
Limitation due to physical health condition
15.11±2.26
14.68±2.31
0.002
14.21±2.68
14.53±3.15
0.055
-0.42±0.51
0.32±0.67
0.001
Limitation caused by emotional health status
11.42±2.19
11.68±2.45
0.056
11.16±3.24
12.42±2.83
<0.001
0.26±0.56
1.26±1.15
0.002
Energy and vitality
10.79±1.151
11.16±1.64
0.005
10.47±1.37
11.00±1.89
0.471
0.37±0.50
0.26±1.56
0.782
Emotional health
16.37±1.74
16.37±1.74
1.000
17.05±2.72
17.58±3.08
0.249
0.00±0.82
0.53±1.93
0.280
Social performance
6.05±0.85
6.21±1.51
0.083
6.21±1.27
6.47±1.26
0.056
0.16±0.37
0.26±0.56
0.501
Pain
6.21±1.51
5.79±1.44
0.002
5.95±1.99
5.53±2.41
0.119
-0.42±0.51
-0.42±1.12
1.000
Cortisol levels
6.19±1.96
6.37±2.02
0.211
8.37±3.37
6.12±2.57
0.042
0.18±0.60
-2.25±4.48
0.031
Depression, Anxiety, Stress (DASS-21)
16 (10-30)
16 (10-28)
0.042
14 (8-24)
7 (6-13)
0.003
0 (-2-0)
-5 (-10-1)
<0.001
Beck Anxiety Inventory (BAI)
9 (3-11)
7 (3-10)
0.047
8 (4-15)
6 (4-13)
<0.001
-1 (-2-0)
-1 (-4-0)
0.235
متغیر
کنترل.قبل
کنترل.بعد
مقدارp.کنترل
مداخله.قبل
مداخله. بعد
مقدارp.مداخله
تفاوت.کنترل
تفاوت.مداخله
pمقدار.تفاوت
شاخص توده بدنی(BMI)
27.47±2.58
27.51±2.57
0.217
29.35±1.63
29.40±1.57
0.488
0.04±0.13
0.05±0.23
0.844
قندخون ناشتا(FBS)
142.89±42.58
142±41.70
0.601
154.26±26.97
148.42±12.44
0.251
0.89±7.33-
5.84±21.47-
0.352
وضعیت ویتامینB5تغذیه ایی
5.97±1.30
5.83±1.29
0.164
4.91±0.56
4.97±0.51
0.202
0.14±0.41
0.06±0.19
0.073
اضطراب صفتی
48.21±5.88
49.11±5.85
0.056
48.53±6.23
46.89±6.80
0.047
0.89±1.91
1.63±3.74-
0.014
اضطراب موقعیتی
48.47±3.39
48.95±3.70
0.432
49.37±5.13
46.42±5.26
0.002
0.47±2.57
2.95±3.50-
0.002
سلامت عمومی
18.32±1.11
18.37±1.42
0.790
18.37±1.16
18.05±1.68
0.187
0.05±0.85
0.32±1.00-
0.229
عملکردجسمانی
23.00±2.19
23.72±2.22
0.007
24.84±2.34
25.68±3.00
0.145
0.42±0.61
0.84±2.41
0.469
محدودیت ناشی ازوضعیت سلامت جسمانی
15.11±2.26
14.68±2.31
0.002
14.21±2.68
14.53±3.15
0.055
0.42±0.51-
0.32±0.67
0.001
محدودیت ناشی ازوضعیت سلامت هیجانی
11.42±2.19
11.68±2.45
0.056
11.16±3.24
12.42±2.83
<0.001
0.26±0.56
1.26±1.15
0.002
انرژی ونشاط
10.79±1.151
11.16±1.64
0.005
10.47±1.37
11.00±1.89
0.471
0.37±0.50
0.26±1.56
0.782
سلامت عاطفی
16.37±1.74
16.37±1.74
1.000
17.05±2.72
17.58±3.08
0.249
0.00±0.82
0.53±1.93
0.280
عملکرداجتماعی
6.05±0.85
6.21±1.51
0.083
6.21±1.27
6.47±1.26
0.056
0.16±0.37
0.26±0.56
0.501
درد
6.21±1.51
5.79±1.44
0.002
5.95±1.99
5.53±2.41
0.119
0.42±0.51-
0.42±1.12-
1.000
سطح کورتیزول
6.19±1.96
6.37±2.02
0.211
8.37±3.37
6.12±2.57
0.042
0.18±0.60
2.25±4.48-
0.031
نمره افسردگی
(10-30)16
(10-28)16
0.042
(8-24)14
(6-13)7
0.003
(2-0-)0
(10-1-)5-
<0.001
نمره اضطراب
(3-11)9
(3-10)7
0.047
(4-15)8
(4-13)6
<0.001
(2-0-)1-
(4-0-)1-
0.235
متغیر
کنترل.قبل
کنترل.بعد
مقدارp.کنترل
مداخله.قبل
مداخله. بعد
مقدارp.مداخله
تفاوت.کنترل
تفاوت.مداخله
pمقدار.تفاوت
شاخص توده بدنی(BMI)
27.47±2.58
27.51±2.57
0.217
29.35±1.63
29.40±1.57
0.488
0.04±0.13
0.05±0.23
0.844
قندخون ناشتا(FBS)
142.89±42.58
142±41.70
0.601
154.26±26.97
148.42±12.44
0.251
0.89±7.33-
5.84±21.47-
0.352
وضعیت ویتامینB5تغذیه ایی
5.97±1.30
5.83±1.29
0.164
4.91±0.56
4.97±0.51
0.202
0.14±0.41
0.06±0.19
0.073
اضطراب صفتی
48.21±5.88
49.11±5.85
0.056
48.53±6.23
46.89±6.80
0.047
0.89±1.91
1.63±3.74-
0.014
اضطراب موقعیتی
48.47±3.39
48.95±3.70
0.432
49.37±5.13
46.42±5.26
0.002
0.47±2.57
2.95±3.50-
0.002
سلامت عمومی
18.32±1.11
18.37±1.42
0.790
18.37±1.16
18.05±1.68
0.187
0.05±0.85
0.32±1.00-
0.229
عملکردجسمانی
23.00±2.19
23.72±2.22
0.007
24.84±2.34
25.68±3.00
0.145
0.42±0.61
0.84±2.41
0.469
محدودیت ناشی ازوضعیت سلامت جسمانی
15.11±2.26
14.68±2.31
0.002
14.21±2.68
14.53±3.15
0.055
0.42±0.51-
0.32±0.67
0.001
محدودیت ناشی ازوضعیت سلامت هیجانی
11.42±2.19
11.68±2.45
0.056
11.16±3.24
12.42±2.83
<0.001
0.26±0.56
1.26±1.15
0.002
انرژی ونشاط
10.79±1.151
11.16±1.64
0.005
10.47±1.37
11.00±1.89
0.471
0.37±0.50
0.26±1.56
0.782
سلامت عاطفی
16.37±1.74
16.37±1.74
1.000
17.05±2.72
17.58±3.08
0.249
0.00±0.82
0.53±1.93
0.280
عملکرداجتماعی
6.05±0.85
6.21±1.51
0.083
6.21±1.27
6.47±1.26
0.056
0.16±0.37
0.26±0.56
0.501
درد
6.21±1.51
5.79±1.44
0.002
5.95±1.99
5.53±2.41
0.119
0.42±0.51-
0.42±1.12-
1.000
سطح کورتیزول
6.19±1.96
6.37±2.02
0.211
8.37±3.37
6.12±2.57
0.042
0.18±0.60
2.25±4.48-
0.031
نمره افسردگی
(10-30)16
(10-28)16
0.042
(8-24)14
(6-13)7
0.003
(2-0-)0
(10-1-)5-
<0.001
نمره اضطراب
(3-11)9
(3-10)7
0.047
(4-15)8
(4-13)6
<0.001
(2-0-)1-
(4-0-)1-
0.235
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There have been limited research on the impact of a particular dietary pattern, like consuming pantothenic acid, on the emergence of stress, anxiety, and depression during diabetes induction. According to this issue, this study was designed. The study involved 38 patients aged 30–65 with type 2 diabetes, divided into two groups receiving vitamin B5 and a control group. The intervention group received 250 mg of vitamin B5 tablets for two months, and stress, anxiety, and depression parameters and the level of cortisol were measured at the start and end of the study. The results showed that in the intervention group, situational anxiety (P<0.01), cortisol level (P<0.05), depression score (P<0.01), and anxiety score of Dass-21 (P = 0.001) after the intervention were significantly lower than before the intervention. The difference (after-before) between trait anxiety (P<0.05), situational anxiety (P = 0.002), and anxiety score (P<0.001) in the intervention group was significantly lower than the control group. Also, the difference (after-before) in the limitation due to physical health status (P = 0.001), limitation due to emotional health status (P = 0.002), and cortisol level (P = 0.031) in the intervention group was significantly higher than the control group. Vitamin B5 supplementation may reduce depression and cortisol levels in type 2 diabetes patients but doesn't affect anxiety, highlighting the need for future studies to understand its role.
There have been limited research on the impact of a particular dietary pattern, like consuming pantothenic acid, on the emergence of stress, anxiety, and depression during diabetes induction. According to this issue, this study was designed. The study involved 38 patients aged 30–65 with type 2 diabetes, divided into two groups receiving vitamin B5 and a control group. The intervention group received 250 mg of vitamin B5 tablets for two months, and stress, anxiety, and depression parameters and the level of cortisol were measured at the start and end of the study. The results showed that in the intervention group, situational anxiety (P<0.01), cortisol level (P<0.05), depression score (P<0.01), and anxiety score of Dass-21 (P = 0.001) after the intervention were significantly lower than before the intervention. The difference (after-before) between trait anxiety (P<0.05), situational anxiety (P = 0.002), and anxiety score (P<0.001) in the intervention group was significantly lower than the control group. Also, the difference (after-before) in the limitation due to physical health status (P = 0.001), limitation due to emotional health status (P = 0.002), and cortisol level (P = 0.031) in the intervention group was significantly higher than the control group. Vitamin B5 supplementation may reduce depression and cortisol levels in type 2 diabetes patients but doesn't affect anxiety, highlighting the need for future studies to understand its role.
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تحقیقات محدودی در مورد تأثیر یک الگوی غذایی خاص، مانند مصرف اسید پانتوتنیک، بر ظهور استرس، اضطراب و افسردگی در طی القای دیابت انجام شده است. با توجه به این موضوع، این پژوهش طراحی شد. این مطالعه شامل 38 بیمار 30 تا 65 ساله مبتلا به دیابت نوع 2 بود که به دو گروه دریافت کننده ویتامین B5 و یک گروه کنترل تقسیم شدند. گروه مداخله به مدت دو ماه 250 میلی گرم قرص ویتامین B5 دریافت کردند و پارامترهای استرس، اضطراب و افسردگی و سطح کورتیزول در ابتدا و انتهای مطالعه اندازه گیری شد. نتایج نشان داد که در گروه مداخله، اضطراب موقعیتی (01/0P<)، سطح کورتیزول (05/0P<)، نمره افسردگی (01/0P<) و نمره اضطراب Dass-21 (001/0P=) پس از مداخله معنی‌دار بود. کمتر از قبل از مداخله تفاوت (بعد از قبل) بین اضطراب صفت (05/0P<)، اضطراب موقعیتی (002/0 = P) و نمره اضطراب (001/0>P) در گروه مداخله به طور معنی‌داری کمتر از گروه کنترل بود. همچنین تفاوت (بعد از قبل) در محدودیت ناشی از وضعیت سلامت جسمانی (001/0 = P)، محدودیت ناشی از وضعیت سلامت عاطفی (002/0 = P) و سطح کورتیزول (031/0 = P) در گروه مداخله به‌طور معنی‌داری بیشتر بود. نسبت به گروه کنترل مکمل ویتامین B5 ممکن است میزان افسردگی و کورتیزول را در بیماران دیابتی نوع 2 کاهش دهد، اما بر اضطراب تأثیری ندارد و نیاز به مطالعات آینده برای درک نقش آن را برجسته می کند.
تحقیقات محدودی در مورد تأثیر یک الگوی غذایی خاص، مانند مصرف اسید پانتوتنیک، بر ظهور استرس، اضطراب و افسردگی در طی القای دیابت انجام شده است. با توجه به این موضوع، این پژوهش طراحی شد. این مطالعه شامل 38 بیمار 30 تا 65 ساله مبتلا به دیابت نوع 2 بود که به دو گروه دریافت کننده ویتامین B5 و یک گروه کنترل تقسیم شدند. گروه مداخله به مدت دو ماه 250 میلی گرم قرص ویتامین B5 دریافت کردند و پارامترهای استرس، اضطراب و افسردگی و سطح کورتیزول در ابتدا و انتهای مطالعه اندازه گیری شد. نتایج نشان داد که در گروه مداخله، اضطراب موقعیتی (01/0P<)، سطح کورتیزول (05/0P<)، نمره افسردگی (01/0P<) و نمره اضطراب Dass-21 (001/0P=) پس از مداخله معنی‌دار بود. کمتر از قبل از مداخله تفاوت (بعد از قبل) بین اضطراب صفت (05/0P<)، اضطراب موقعیتی (002/0 = P) و نمره اضطراب (001/0>P) در گروه مداخله به طور معنی‌داری کمتر از گروه کنترل بود. همچنین تفاوت (بعد از قبل) در محدودیت ناشی از وضعیت سلامت جسمانی (001/0 = P)، محدودیت ناشی از وضعیت سلامت عاطفی (002/0 = P) و سطح کورتیزول (031/0 = P) در گروه مداخله به‌طور معنی‌داری بیشتر بود. نسبت به گروه کنترل مکمل ویتامین B5 ممکن است میزان افسردگی و کورتیزول را در بیماران دیابتی نوع 2 کاهش دهد، اما بر اضطراب تأثیری ندارد و نیاز به مطالعات آینده برای درک نقش آن را برجسته می کند.
Protocol summary
Study aim
Determining the effect of vitamin B5 administration on stress; depression; anxiety, oxidative stress level and cortisol level in patients with type 2 diabetes
Design
Clinical trial with a control group, double-blind, randomized, phase 2 on 48 patients. The randomized treatment allocation sequence will be generated by the statistical consultant using a table of random numbers.
Settings and conduct
The current clinical trial study will be conducted on 48 patients with type 2 diabetes referred to the Imam Ali clinic in Shahrekord. After the diagnosis of type 2 diabetes and stress, anxiety, or depression, their cortisol level will be evaluated. Then, for two months, they will be given vitamin B5 tablets (250 mg) or a placebo in a blinded manner, and the status of the investigated parameters will be checked at the end of the two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 30-65 years; not taking oral contraceptives in the last month; non-smokers; People who have not received vitamin B supplements at least 3 months before the study; People who are not professional athletes.
Exclusion criteria: non-cooperation of patients to participate in the study; the presence of congenital anxiety diseases; incomplete completion of the questionnaire; People taking combined oral blood sugar-lowering drugs such as Sinuripa tablets; People taking drugs related to severe depression (bipolar); People taking vitamin B5 supplements before starting the tests
Intervention groups
The intervention group: will receive vitamin B5 chewable tablets along with metformin/insulin.
The control group: the group of diabetic patients who will receive metformin/insulin along with placebo.
Main outcome variables
Average score of depression; Average score of anxiety; Average score of stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230702058641N2
Registration date:2024-02-01, 1402/11/12
Registration timing:registered_while_recruiting
Last update:2024-09-21, 1403/06/31
Update count:1
Registration date
2024-02-01, 1402/11/12
Registrant information
Name
Reihaneh Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 205 8035
Email address
reihaneh.sadeghian5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of vitamin B5 administration compared to placebo on stress; depression; Anxiety, oxidative stress level and serum cortisol level in type 2 diabetes patients
Public title
The effect of vitamin B5 on stress; depression and anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-65 years
People who are not professional athletes.
Receiving metformin/insulin.
Patients should not take melatonin, aspirin, D3, omega3 during the study period.
Not taking oral contraceptives in the last month
people who have not received vitamin B supplements at least 3 months before the study.
Exclusion criteria:
Non-cooperation of patients to participate in the study
Use of corticosteroids and anticoagulants in the last month
Smokers
The existence of congenital cognitive and anxiety diseases
Incomplete completion of the questionnaire
People taking combined oral hypoglycemic drugs such as Sinuripa tablets
People taking drugs related to severe depression (bipolar)
People taking vitamin B5 supplements before starting the tests
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Diabetic patients are randomly divided into two groups "control and intervention" after examination and if they meet the criteria to enter the plan. By using online sites for random allocation, random block method with blocks of 4 will be used. For the random sequence, a numerical code will be defined and people will receive the numerical code in the same order as they enter and will be placed in groups according to the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind (researcher and patients do not know which person is assigned to which treatment group). Patients were also blinded according to the received intervention, which is the use of tablets with the same shape, taste, and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.SKUMS.MED.REC.1402.063
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Score of depression
Timepoint
At the beginning of the study and after two months after taking vitamin B5 or placebo
Method of measurement
DASS-21 Scale
2
Description
Score of anxiety
Timepoint
At the beginning of the study and after two months after taking vitamin B5 or placebo
Method of measurement
DASS-21 Scale
3
Description
Score of stress
Timepoint
At the beginning of the study and after two months after taking vitamin B5 or placebo
Method of measurement
DASS-21 Scale
Secondary outcomes
1
Description
Cortisol level
Timepoint
At the beginning of the study and after two months
Method of measurement
ELISA technique
2
Description
Nitric oxide levels
Timepoint
At the beginning of the study and after two months
Method of measurement
Gress method
3
Description
Malondialdehyde level
Timepoint
At the beginning of the study and after two months
Method of measurement
Thiobarbituric acid method
4
Description
Antioxidant capacity
Timepoint
At the beginning of the study and after two months
Method of measurement
FRAP measurement
Intervention groups
1
Description
Intervention group: vitamin B5 chewable tablet with a dose of 250 mg (produced by Shehab Pharmaceutical Company) once a day, which will be given to them along with metformin/insulin for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo along with metformin/insulin will be given to them for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic; Shahrekord University of Medical Sciences
Full name of responsible person
Reihaneh Sadeghian
Street address
Imam Ali (A.S.) Specialized Clinic; Shariati Blvd.; Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 915 205 8035
Email
reihaneh.sadeghian5@gmail.com
Web page address
https://orcid.org/0000-0002-0777-002X
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Golshan Taghipour
Street address
Clinic No. 1 of Hajar Hospital; Parastar street; Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 913 184 2580
Email
golshan.taghipour@gmail.com
Web page address
https://imamaliclinic.skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reihaneh Sadeghian
Position
Assistant Professor of physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Headquarters of Shahrekord University of Medical Sciencesl; Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 9509
Email
reihaneh.sadeghian5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Golshan Taghipour
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used after obtaining permission from both supervisors
From where data/document is obtainable
Reihane Sadeghian; Adress: University Headquarters; Kashani Blvd.; Shahrekord. Postal code: 8815713471. Phone number: 038-0333061-5-3333061; Email: reihaneh.sadeghian5@gmail.com
What processes are involved for a request to access data/document
The data can be accessed after the official letter from the Research and Technology Vice-Chancellor of the relevant university.
Comments
Trial results
Please tick if results have been published
Yes
Summary result posting date
2024-09-21, 1403/06/31
Table of baseline comparison
Variable
Group
Control.N=19
intervention.N=19
p-value
Frequency (Percentage)
Gender
male
9(47.4)
7(36.8)
0.511
female
10(52.6)
12(63.2)
Marital status
Single
0(0)
0(0)
1.000
marreid
19(100)
(100)19
Blood sugar lowering drug
Metformin
11(57.9)
15(78.9)
0.163
Insulin
8(42.1)
4(21.1)
Family History
1st degree family
0(0.0)
0(0.0)
2nd degree family
(100)19
(100)19
1.000
No record
0(0.0)
0(0.0)
Level of Education
Illiterate
7(36.8)
6(31.6)
0.723
Primary education
7(36.8)
9(47.4)
Secondary education
4(21.1)
2(10.5)
Bachelor 's degree and above
1(5.3)
2(10.5)
Average ± Standard Deviation
Age (years)
56.94 ±9.11
55.21±3.45
0.445
Body mass index (BMI)
27.47 ±2.58
29.35±1.63
0.076
Fasting blood sugar (FBS)
142.89±42.58
154.26 ±26.97
0.333
B5 Vitamin nutritional status
97.5±30.1
91.4±56.0
0.095
Trait anxiety
48.21±5.88
48.53±6.23
0.873
Situational anxiety
48.47±3.38
49.37±5.13
0.530
General health
18.32±1.11
18.37±1.16
0.887
Physical performance
23.00±2.19
24.84±2.34
0.017
Limitation due to physical health condition
15.11±2.26
14.21±2.68
0.273
Limitation caused by emotional health status
11.42±2.19
11.16±3.24
0.771
Energy and vitality
10.79±1.51
10.74±1.51
0.911
Emotional health
16.37±1.74
17.05±2.72
0.361
Social performance
6.05±0.85
6.21±1.27
0.655
Pain
6.21±1.51
5.95±1.99
0.649
Cortisol levels
6.19±1.96
8.37 ±3.37
0.020
Middle (first and third quadrants)
Depression, Anxiety, Stress (DASS-21)
16 (10-30)
14 (8-24)
0.704
Beck Anxiety Inventory (BAI)
9 (3-11)
8 (4-15)
0.520
Participant flow diagram
Reihaneh Sadeghian
Supervisor
Seyed Hasan Hosseini
MD student
Golshan Taghipour
Supervisor
Motahareh Sadat Mirhaj
Advisor
Ammar Salehi
Advisor
Mahboobe Taghipour
Scientific Co-Workers
Alireza Amirbeigi
Scientific Co-Workers
Table of variable outcomes' results
control
intervention
difference
variables
before
after
p-value
before
after
p-value
control
internention
p-value
Body mass index (BMI)
27.47±2.58
27.51±2.57
0.217
29.35±1.63
29.40±1.57
0.488
0.04±0.13
0.05±0.23
0.844
Fasting blood sugar (FBS)
142.89±42.58
142±41.70
0.601
154.26±26.97
148.42±12.44
0.251
-0.89±7.33
-5.84±21.47
0.352
B5 Vitamin nutritional status
5.97±1.30
5.83±1.29
0.164
4.91±0.56
4.97±0.51
0.202
0.14±0.41
0.06±0.19
0.073
Trait anxiety
48.21±5.88
49.11±5.85
0.056
48.53±6.23
46.89±6.80
0.047
0.89±1.91
-1.63±3.74
0.014
Situational anxiety
48.47±3.39
48.95±3.70
0.432
49.37±5.13
46.42±5.26
0.002
0.47±2.57
-2.95±3.50
0.002
General health
18.32±1.11
18.37±1.42
0.790
18.37±1.16
18.05±1.68
0.187
0.05±0.85
-0.32±1.00
0.229
Physical performance
23.00±2.19
23.72±2.22
0.007
24.84±2.34
25.68±3.00
0.145
0.42±0.61
0.84±2.41
0.469
Limitation due to physical health condition
15.11±2.26
14.68±2.31
0.002
14.21±2.68
14.53±3.15
0.055
-0.42±0.51
0.32±0.67
0.001
Limitation caused by emotional health status
11.42±2.19
11.68±2.45
0.056
11.16±3.24
12.42±2.83
<0.001
0.26±0.56
1.26±1.15
0.002
Energy and vitality
10.79±1.151
11.16±1.64
0.005
10.47±1.37
11.00±1.89
0.471
0.37±0.50
0.26±1.56
0.782
Emotional health
16.37±1.74
16.37±1.74
1.000
17.05±2.72
17.58±3.08
0.249
0.00±0.82
0.53±1.93
0.280
Social performance
6.05±0.85
6.21±1.51
0.083
6.21±1.27
6.47±1.26
0.056
0.16±0.37
0.26±0.56
0.501
Pain
6.21±1.51
5.79±1.44
0.002
5.95±1.99
5.53±2.41
0.119
-0.42±0.51
-0.42±1.12
1.000
Cortisol levels
6.19±1.96
6.37±2.02
0.211
8.37±3.37
6.12±2.57
0.042
0.18±0.60
-2.25±4.48
0.031
Depression, Anxiety, Stress (DASS-21)
16 (10-30)
16 (10-28)
0.042
14 (8-24)
7 (6-13)
0.003
0 (-2-0)
-5 (-10-1)
<0.001
Beck Anxiety Inventory (BAI)
9 (3-11)
7 (3-10)
0.047
8 (4-15)
6 (4-13)
<0.001
-1 (-2-0)
-1 (-4-0)
0.235
Table of adverse events
First publication date
empty
Abstract of published paper
There have been limited research on the impact of a particular dietary pattern, like consuming pantothenic acid, on the emergence of stress, anxiety, and depression during diabetes induction. According to this issue, this study was designed. The study involved 38 patients aged 30–65 with type 2 diabetes, divided into two groups receiving vitamin B5 and a control group. The intervention group received 250 mg of vitamin B5 tablets for two months, and stress, anxiety, and depression parameters and the level of cortisol were measured at the start and end of the study. The results showed that in the intervention group, situational anxiety (P<0.01), cortisol level (P<0.05), depression score (P<0.01), and anxiety score of Dass-21 (P = 0.001) after the intervention were significantly lower than before the intervention. The difference (after-before) between trait anxiety (P<0.05), situational anxiety (P = 0.002), and anxiety score (P<0.001) in the intervention group was significantly lower than the control group. Also, the difference (after-before) in the limitation due to physical health status (P = 0.001), limitation due to emotional health status (P = 0.002), and cortisol level (P = 0.031) in the intervention group was significantly higher than the control group. Vitamin B5 supplementation may reduce depression and cortisol levels in type 2 diabetes patients but doesn't affect anxiety, highlighting the need for future studies to understand its role.