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The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP and serum level of thyroid hormones and oxidative stress indices of SOD, PAB, GPx, TAC and gene expression of TNF-α, IL-10, IL-6, CRP, PPAR-γ، SIRT1، PGC-1α و AMPK in obese people

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History
# Registration date Revision Id
4 2024-05-01, 1403/02/12 312965
3 2023-03-19, 1401/12/28 260744
2 2022-09-17, 1401/06/26 240736
1 2022-08-31, 1401/06/09 238397
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  • Protocol summary

    The effect of boron citrate supplementation on nutritional status, cardiometabolic factors and indices of TNF-α, IL-10, IL-6 and CRP in obese subjects.
    The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, inflammatory indices, serum level of thyroid hormones and oxidative stress indices in obese people
    اثر مکمل‌یاری بورون سیترات بر وضعیت تغذیه‌ای، عوامل کاردیومتابولیکی و شاخصهای التهابی TNF-α، IL-10 ،IL-6 و CRP درافراد چاق
    اثر مکمل یاری بورون سیترات بر وضعیت تغذیه ای، عوامل کاردیومتابولیکی و شاخصهای التهابی، سطوح سرمی هورمون های تیروئیدی و شاخص های استرس اکسیداتیو درافراد چاق
    glucose-insulin-HbA1c-insulin resistance with HOMA-IR score, lipid pattern, systolic and diastolic blood pressure) CRP, TNF-α, IL-10, and IL-6)
    glucose-insulin-HbA1c-insulin resistance with HOMA-IR score, lipid pattern, systolic and diastolic blood pressure) CRP, TNF-α, IL-10, and IL-6

  • General information

    The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP in obese people
    The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP and serum level of thyroid hormones and oxidative stress indices of SOD, PAB, GPx, TAC and gene expression of TNF-α, IL-10, IL-6, CRP, PPAR-γ، SIRT1، PGC-1α و AMPK in obese people
    اثر مکمل یاری بورون سیترات بر وضعیت تغذیه ای، عوامل کاردیومتابولیکی و شاخصهای التهابی TNF-α ،IL-10 ،IL-6 و CRP درافراد چاق
    اثر مکمل یاری بورون سیترات بر وضعیت تغذیه ای، عوامل کاردیومتابولیکی و شاخصهای التهابی TNF-α ،IL-10 ،IL-6 و CRP و سطوح سرمی هورمون های تیروئیدی و شاخص های استرس اکسیداتیو SOD ، PAB ، GPx ، TAC و بیان ژن های TNF-α, IL-10, IL-6, CRP, PPAR-γ SIRT1، PGC-1α و AMPK درافراد چاق

  • Primary outcomes

    #1
    weight
    Weight
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    weight scale
    Weight scale
    #2
    body mass scale
    Body mass index (BMI)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #3
    waist circumstance
    Waist circumference (WC)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    tape measure
    Tape measure
    #4
    waist to hio ratio
    Waist to hip ratio (WHR)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #5
    waist circumstance to height ratio
    Waist to height ratio (WHtR)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #6
    CRP (c-reactive protein)
    C-reactive protein (CRP)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #7
    TNF-α (Tumor necrosis factor-α)
    Tumor necrosis factor-α (TNF-α)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #8
    IL-10
    Interleukin-10 (IL-10)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #9
    IL-6
    Interleukin-6 (IL-6)
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #10
    total body fat mass (FM)
    Hip circumference (HC)
    توده چربی کل بدن
    دور باسن
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    bioelectrical impedance analysis
    Tape measure
    آنالیز امپدانس بیوالکتریک
    متر نواری
    #11
    total body fat‐free mass (FFM)
    empty
    توده بدون چربی کل بدن
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    bioelectrical impedance analysis
    empty
    آنالیز امپدانس بیوالکتریک
    empty
    #12
    hip circumference
    empty
    دور باسن
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مطالعه
    empty
    tape measure
    empty
    متر نواری
    empty

  • Secondary outcomes

    #1
    energy consumption
    Fasting blood sugar (FBS)
    میزان دریافت انرژی
    قند خون ناشتا
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Questionnaire
    Use of an enzymatic kit method
    پرسشنامه
    روش آنزیماتیک با استفاده از کیت
    #2
    macronutrient consumption
    Fasting insulin levels
    دریافت درشت مغذی‌ها
    سطوح انسولین ناشتا
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Questionnaire
    ELISA
    پرسشنامه
    الایزا
    #3
    blood glucose
    Insulin resistance with HOMA-IR score
    قند خون
    مقاومت انسولینی با امتیاز HOMA-IR
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Use of an enzymatic kit method
    Calculation based on formula
    روش آنزیماتیک با استفاده از کیت
    محاسبه بر اساس فرمول
    #4
    Fasting insulin levels
    Low density lipoprotein cholesterol (LDL-c)
    سطوح انسولین ناشتا
    کلسترول LDL
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    ELISA
    Calculation based on the Friedewald formula
    الایزا
    محاسبه بر اساس فرمول Friedewald
    #5
    Insulin resistance with HOMA-IR score
    High density lipoprotein cholesterol (HDL-c)
    مقاومت انسولینی با امتیاز HOMA-IR
    کلسترول HDL
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Calculation based on formula
    Use of an enzymatic kit method
    محاسبه بر اساس فرمول
    روش آنزیماتیک با استفاده از کیت
    #6
    LDL-c
    Total cholesterol (TC)
    کلسترول LDL
    کلسترول تام
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Calculation based on the Friedewald formula
    Use of an enzymatic kit method
    محاسبه بر اساس فرمول Friedewald
    روش آنزیماتیک با استفاده از کیت
    #7
    HDL-c
    Triglyceride (TG)
    کلسترول HDL
    تری‌گلیسیرید
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    #8
    total cholesterol
    Systolic blood pressure (SBP)
    کلسترول تام
    فشار خون سیستولی
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Use of an enzymatic kit method
    Mercury manometer
    روش آنزیماتیک با استفاده از کیت
    فشارسنج جیوه‌ای
    #9
    Triglyceride
    Diastolic blood pressure (DBP)
    تری‌گلیسیرید
    فشار خون دیاستولی
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Use of an enzymatic kit method
    Mercury manometer
    روش آنزیماتیک با استفاده از کیت
    فشارسنج جیوه‌ای
    #10
    systolic blood pressure
    Quantitative insulin sensitivity check index (QUICKI)
    فشار خون سیستولی
    شاخص بررسی کمی حساسیت به انسولین
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    mercury manometer
    Calculation based on formula
    فشارسنج جیوه‌ای
    محاسبه بر اساس فرمول
    #11
    diastolic blood pressure
    Serum level of triiodothyronine (T3)
    فشار خون دیاستولی
    سطح سرمی تری یدوتیرونین
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    mercury manometer
    ELISA
    فشارسنج جیوه‌ای
    الایزا
    #12
    QUICKI
    Serum level of tetraiodothyronine (T4)
    شاخص بررسی کمی حساسیت به انسولین
    سطح سرمی تترایدوتیرونین
    ابتدا و انتهای مطالعه
    ابتدا و انتهای مداخله
    Calculation based on formula
    ELISA
    محاسبه بر اساس فرمول
    الایزا
    #13
    empty
    Serum level of thyroid Stimulating hormone (TSH)
    empty
    سطح سرمی هورمون محرک تیروئیدی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    ELISA
    empty
    الایزا
    #14
    empty
    Prooxidant - Antioxidant balance (PAB)
    empty
    تعادل آنتی اکسیدانی - پرو اکسیدانی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    ELISA
    empty
    الایزا
    #15
    empty
    Superoxide dismutase (SOD)
    empty
    سوپراکسید دیسموتاز
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometric method and the Randox kit
    empty
    اسپکتروفوتومتری و کیت رندوکس
    #16
    empty
    Glutathione Peroxidase (GPX)
    empty
    گلوتاتیون پر اکسیداز
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometricmethod and the Randox kit
    empty
    اسپکتروفوتومتری و کیت رندوکس
    #17
    empty
    Total antioxidant capacity (TAC)
    empty
    ظرفیت تام آنتی اکسیدانی
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Spectrophotometricmethod and the Randox kit
    empty
    اسپکتروفوتومتری و کیت رندوکس
    #18
    empty
    Gene expression of CRP
    empty
    بیان ژن پروتئین واکنشی C
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #19
    empty
    Gene expression of TNF-α
    empty
    بیان ژن TNF-α
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #20
    empty
    Gene expression of IL-6
    empty
    بیان ژن اینترلوکین 6
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #21
    empty
    Gene expression of IL-10
    empty
    بیان ژن اینترلوکین 10
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #22
    empty
    Gene expression of AMPK
    empty
    بیان ژن AMPK
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #23
    empty
    Gene expression of PPAR-γ
    empty
    بیان ژن PPAR-γ
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #24
    empty
    Gene expression of SIRT1
    empty
    بیان ژن SIRT1
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #25
    empty
    Gene expression of PGC-1α
    empty
    بیان ژن PGC-1α
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Real-Time polymerase chain reaction (PCR) method
    empty
    واکنش زنجیره‌ای پلیمراز کمّی
    #26
    empty
    Total body fat mass (FM)
    empty
    توده چربی کل بدن
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Bioelectrical impedance analysis
    empty
    آنالیز امپدانس بیوالکتریک
    #27
    empty
    Total body fat free mass (FFM)
    empty
    توده بدون چربی کل بدن
    empty
    Beginning and end of the trial
    empty
    ابتدا و انتهای مداخله
    empty
    Bioelectrical impedance analysis
    empty
    آنالیز امپدانس بیوالکتریک

Protocol summary

Study aim
The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, inflammatory indices, serum level of thyroid hormones and oxidative stress indices in obese people
Design
randomized, double-blinded, controlled trial, containing supplement and intervention groups, with parallel groups, sample size of 60 participants (30 in each group), RAS (Random Allocation Software) used for randomization.
Settings and conduct
This study will be conducted on 60 obese patients at Tabriz University of Medical Sciences Faculty of Nutrition. Patients will be divided into 2 equal groups of supplement and placebo and will receive boron citrate and placebo (maltodextrin) respectively for 12 weeks. In order to blind all researchers and participants, a person not involved in the experiment randomly assigns a list to the participants in each group and labels all identical containers (in appearance and color) according to their number. Therefore, participants will be unaware of the type of intervention they are receiving. The random sequence will also be unpredictable.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obese people/Exclusion criteria: pregnancy and breastfeeding, smoking, following special diets 3 months before the study, taking chemical or herbal weight loss drugs, taking hepatotoxic drugs, taking blood pressure control drugs and blood lipid-lowering drugs
Intervention groups
Participants will be divided into two groups of 30 people: intervention group (1 capsule containing 10 mg boron citrate per day before lunch) and placebo group (1 capsule per day of maltodextrin before lunch) and will use the supplement or placebo for 12 weeks.
Main outcome variables
glucose-insulin-HbA1c-insulin resistance with HOMA-IR score, lipid pattern, systolic and diastolic blood pressure) CRP, TNF-α, IL-10, and IL-6

General information

Reason for update
Delay in obtaining the necessary financial credit to start the project
Acronym
IRCT registration information
IRCT registration number: IRCT20220806055624N1
Registration date: 2022-08-31, 1401/06/09
Registration timing: prospective

Last update: 2024-08-29, 1403/06/08
Update count: 3
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Helda Tutunchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
helda.nutrition@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of boron citrate supplementation on nutritional status, cardiometabolic factors, and inflammatory indices of TNF-α, IL-10, IL-6, and CRP and serum level of thyroid hormones and oxidative stress indices of SOD, PAB, GPx, TAC and gene expression of TNF-α, IL-10, IL-6, CRP, PPAR-γ، SIRT1، PGC-1α و AMPK in obese people
Public title
Boron citrate in obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI: 30–40 (kg/m²) Willingness to participate in the study
Exclusion criteria:
Athlete, pregnancy, lactation and menopause in women Under infertility treatment, taking birth control pills and estrogen Smoking and history of alcohol consumption Following a special diet three months before the study Use of chemical or herbal drugs for weight loss and use of hepatotoxic drugs such as phenytoin, amoxifene, lithium, blood pressure control drugs and blood lipid lowering drugs (statins), drugs that increase insulin sensitivity. Taking antibiotics or supplements affecting liver enzyme levels Weight loss surgery in the last year or strict weight loss diets in the last three months Using corticosteroid and non-steroidal anti-inflammatory drugs and any supplements for 3 months before the study or during the study Cardiovascular diseases, liver, kidney, intestinal, thyroid and parathyroid dysfunction, biliary disease, known autoimmune diseases, polycystic ovary syndrome, cancers and malabsorption diseases such as sprue and Crohn's Having symptoms of infectious or inflammatory disease or recent surgery Performed or candidate for liver transplant
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To stratify individuals into distinct strata and blocks, stratified block randomization will be implemented based on age (18-40 vs. 40-60 years) and gender (male vs. female). For each individual placed in a given stratum, a matched individual is considered based on these variables in the same stratum. As a result, two participants with similar characteristics (for age and gender) are placed in the same stratum. Finally, each stratum will be randomly allocated to the intervention or control groups using Random Allocation Software (RAS). Participants and researchers will be blinded to the randomization and allocation until the end of the study. The randomization list will be provided by the pharmacist of the research center at the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researchers will be blind to the type of supplements (boron citrate or placebo). The person responsible for preparing the supplement packages (a person completely unrelated to the study) will be asked to assign a three-digit code to each of the two received supplements (boron citrate or placebo) and keep the codes for himself until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The specialized committee of ethics in biomedical research
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.TBZMED.REC.1401.350

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Weight
Timepoint
Beginning and end of the trial
Method of measurement
Weight scale

2

Description
Body mass index (BMI)
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

3

Description
Waist circumference (WC)
Timepoint
Beginning and end of the trial
Method of measurement
Tape measure

4

Description
Waist to hip ratio (WHR)
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

5

Description
Waist to height ratio (WHtR)
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

6

Description
C-reactive protein (CRP)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

7

Description
Tumor necrosis factor-α (TNF-α)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

8

Description
Interleukin-10 (IL-10)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

9

Description
Interleukin-6 (IL-6)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

10

Description
Hip circumference (HC)
Timepoint
Beginning and end of the trial
Method of measurement
Tape measure

Secondary outcomes

1

Description
Fasting blood sugar (FBS)
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

2

Description
Fasting insulin levels
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

3

Description
Insulin resistance with HOMA-IR score
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

4

Description
Low density lipoprotein cholesterol (LDL-c)
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on the Friedewald formula

5

Description
High density lipoprotein cholesterol (HDL-c)
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

6

Description
Total cholesterol (TC)
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

7

Description
Triglyceride (TG)
Timepoint
Beginning and end of the trial
Method of measurement
Use of an enzymatic kit method

8

Description
Systolic blood pressure (SBP)
Timepoint
Beginning and end of the trial
Method of measurement
Mercury manometer

9

Description
Diastolic blood pressure (DBP)
Timepoint
Beginning and end of the trial
Method of measurement
Mercury manometer

10

Description
Quantitative insulin sensitivity check index (QUICKI)
Timepoint
Beginning and end of the trial
Method of measurement
Calculation based on formula

11

Description
Serum level of triiodothyronine (T3)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

12

Description
Serum level of tetraiodothyronine (T4)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

13

Description
Serum level of thyroid Stimulating hormone (TSH)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

14

Description
Prooxidant - Antioxidant balance (PAB)
Timepoint
Beginning and end of the trial
Method of measurement
ELISA

15

Description
Superoxide dismutase (SOD)
Timepoint
Beginning and end of the trial
Method of measurement
Spectrophotometric method and the Randox kit

16

Description
Glutathione Peroxidase (GPX)
Timepoint
Beginning and end of the trial
Method of measurement
Spectrophotometricmethod and the Randox kit

17

Description
Total antioxidant capacity (TAC)
Timepoint
Beginning and end of the trial
Method of measurement
Spectrophotometricmethod and the Randox kit

18

Description
Gene expression of CRP
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

19

Description
Gene expression of TNF-α
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

20

Description
Gene expression of IL-6
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

21

Description
Gene expression of IL-10
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

22

Description
Gene expression of AMPK
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

23

Description
Gene expression of PPAR-γ
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

24

Description
Gene expression of SIRT1
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

25

Description
Gene expression of PGC-1α
Timepoint
Beginning and end of the trial
Method of measurement
Real-Time polymerase chain reaction (PCR) method

26

Description
Total body fat mass (FM)
Timepoint
Beginning and end of the trial
Method of measurement
Bioelectrical impedance analysis

27

Description
Total body fat free mass (FFM)
Timepoint
Beginning and end of the trial
Method of measurement
Bioelectrical impedance analysis

Intervention groups

1

Description
Intervention group: Patients in this group will receive dietary recommendations and boron citrate capsules including 10 mg boron for 12 weeks. Boron citrate capsules is made in Iran, and once a day before lunch will be consumed.
Category
Prevention

2

Description
Control group: Patients in this group will receive dietary recommendations with placebo for 12 weeks. The placebo is starch (containing 10 mg of maltodextrin) and once a day before lunch will be consumed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition Research Center of Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Street address
Nutrition faculty, Tabriz University of Medical Science, Golgasht Avenue, Attar Neyshabouri Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 116 3184
Email
helda.nutrition@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Helda Tutunchi
Position
Assistant Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
helda.nutrition@gmail.com

Sharing plan

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document
Request a document via email
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