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Effects of sumac powder capsule (Rhus coriaria L.) with restricted calorie diet on anthropometric indices, body composition, level of inflammatory biomarkers, oxidative stress, appetite hormones, glycemic indices, lipid profile and depression in obese or overweight women with depression

Protocol summary

Study aim
Determine the effects of sumac powder with calorie-restricted diet on anthropometric indices, body composition, inflammatory factors, oxidative stress, appetite hormones, glycemic indexes, lipids profile and depression symptoms in overweight or obese women with depression
Design
This study is a randomized double-blind controlled clinical trial with two parallel groups. Sixty-six patients are randomly divided into two groups: sumac and control.
Settings and conduct
Invite overweight or obese individuals referring to nutrition clinic of Shahid Beheshti, After examining the criteria for entering the study, 10cc blood samples are taken. food recall questionnaire, depression, appetite and physical activity questionnaire are completed. Supplements are given to individuals for 6 weeks. For double-blind execution of this research, at the start of the study, the collection of Supplement cans are coded by third person as A and B.
Participants/Inclusion and exclusion criteria
Inclusion: overweight and obesity; moderate and mild depression Exclusion: Use of anti-inflammatory drugs ;antidepressants; Diabetes; inflammatory diseases; Infectious diseases; Acute psychiatric disorders; Sensitivity to sumac
Intervention groups
The intervention group receive a weight loss diet and 3 capsules each contains 1000 mg of sumac and control group receive, weight loss diet and 3 placebo capsules (starch) for 12 weeks.
Main outcome variables
Weight; body massindex; waist circumference; hip circumference; waist to hip; body fat percentage; visceral fat; fat free mass; serum level of hs-CRP; TNF-α; IL-6; malondialdehyde; leptin; neuropeptideY; triglyceride; total cholesterol; low density lipoprotein-C; high density lipoprotein-C; glucose; insulin; Insulin resistance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131228015968N6
Registration date: 2019-05-10, 1398/02/20
Registration timing: registered_while_recruiting

Last update: 2019-05-10, 1398/02/20
Update count: 0
Registration date
2019-05-10, 1398/02/20
Registrant information
Name
Atoosa Saidpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences, School of nutrition
Country
Iran (Islamic Republic of)
Phone
-
Email address
a.saidpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-06, 1397/10/16
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of sumac powder capsule (Rhus coriaria L.) with restricted calorie diet on anthropometric indices, body composition, level of inflammatory biomarkers, oxidative stress, appetite hormones, glycemic indices, lipid profile and depression in obese or overweight women with depression
Public title
Effects of sumac powder capsule (Rhus coriaria L.) with restricted calorie diet on obesity and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender Willingness to cooperate Age 20-65 years Body mass index above 24/9 kg/m2 Mild to moderate depression
Exclusion criteria:
Use of anti-inflammation drugs (Steroids and non steroids) Continuous use (more than once a week) of vitamin and mineral supplements with anti-inflammatory and antioxidant properties such as omega-3, vitamin E in the past month Use of weight loss and appetite suppressants Use of antidepressants Diabetes Cases of various autoimmune inflammatory diseases such as multiple sclerosis, rheumatoid arthritis and ... Acute gastrointestinal disease (gastric ulcer, bowel disease, etc.) Chronic kidney or liver disease, with the exception of non-alcoholic fatty liver Infectious diseases up to 1 month before the start of the study Acute mental disorders, Bipolar Disorders, Schizophrenia Weight loss diet in one months ago Surgery in a recent month Sensitivity to sumac Pregnancy Lactation
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are classified into overweight and obese groups based on body mass index and are randomly assigned to one of the sumac group or placebo group. The random grouping of the two groups is done using Stratified Blocked Randomization. Separate randomization is done within each group. The size of the blocks is 4, with two allocations to the intervention group (A) and two allocations to the placebo group (B). With 6 different permutations, AABB, ABAB, BBAA, BABA, ABBA, BAAB will be created.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind clinical trial (patients and researchers). In order to implement this study, at the start of the study, a set of cans contains sumac or placebo are coded by a third party (someone other than the researchers) as A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Institute of Nutrition Research and Food Industry of the country
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1397.020

2

Ethics committee
Name of ethics committee
Ethics committee of Institute of Nutrition Research and Food Industry of the country
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1397.019

3

Ethics committee
Name of ethics committee
Ethics committee of Institute of Nutrition Research and Food Industry of the country
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Ave., Shahrake Qods(Gharb) town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1398.001

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

2

Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild

Primary outcomes

1

Description
Body weight
Timepoint
before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
seca scale

2

Description
Body Mass Index
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
calculation (kg/m2)

3

Description
Waist Circumference
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
Meter strip

4

Description
Hip circumference
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
Meter strip

5

Description
Waist circumference to hip ratio
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
Calculation

6

Description
Body fat percentage
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
Body Analyzer

7

Description
Visceral fat
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of interventionbefore intervention
Method of measurement
Body Analyzer

8

Description
Body fat free mass
Timepoint
Before intervention, after 6 weeks of intervention and after 12 weeks of intervention
Method of measurement
Body Analyzer

Secondary outcomes

1

Description
Malondialdehyde
Timepoint
Before intervention and after 12 weeks of intervention
Method of measurement
ELISA

2

Description
Serum concentration of Leptin
Timepoint
Before intervention and after 12 weeks of intervention
Method of measurement
ELISA

3

Description
Serum concentration of Neuropeptide Y
Timepoint
Before intervention and after 12 weeks of intervention
Method of measurement
ELISA

4

Description
Serum concentration of hs-CRP
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
ELISA

5

Description
Serum concentration of TNF-alpha
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
ELISA

6

Description
Serum concentration of IL-6
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
ELISA

7

Description
Serum concentration of glucose
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
Enzymatic method

8

Description
Serum concentration of insulin
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
ELISA

9

Description
Serum concentration of triglyceride
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
Enzymatic method

10

Description
Serum concentration of total cholesterol
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
Enzymatic method

11

Description
Serum concentration of High Density Lipoprotein
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
Enzymatic method

12

Description
Serum concentration of low density lipoprotein
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
Enzymatic method

13

Description
HOMA-IR
Timepoint
calculation ([Glucose (mg/dl)]*[Insulin]/405)
Method of measurement
Before intervention, twelve weeks after intervention

14

Description
Appetite
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
simple appetite questionnaire

15

Description
Depression
Timepoint
Before intervention, twelve weeks after intervention
Method of measurement
Beck Depression Inventory

Intervention groups

1

Description
Intervention group: daily intake of 3 g sumac powder as 3 capsules of 1000 mg before each meals with weight reduction diet for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: daily intake of 3 g starch as 3 capsules of 1000 mg before each meals with weight reduction diet for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک تغذیه و رژیم درمانی دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person
Nastaran HarIri
Street address
Baran St.,Hafezi (Arghavan) Ave., Farahzadi Blvd., Qods (Gharb) twon, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nastaranhariri@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition
Full name of responsible person
Esmat Nasseri
Street address
No. 7, Hafezi (Arghavan) st., Farahzdi Blvd., Qods (Gharb) twon, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
Nasseri_esm@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical sciences- School of Nutrition
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
Shahid Beheshti University of Medical sciences- School of Nutrition
Full name of responsible person
Nastaran Hariri
Position
PhD. student of nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
NO. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd, Qods (Gharb) twon, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nastaranhariri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical sciences- School of Nutrition
Full name of responsible person
Atoosa Saidpour
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd., Qods (Gharb) twon, tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7384
Email
atoosa.saidpour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical sciences- School of Nutrition
Full name of responsible person
Nastaran Hariri
Position
PhD. student of nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
NO. 7, Hafezi (Arghavan) Ave., Farahzadi Blvd, Qods (Gharb) twon, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nastaranhariri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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