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Effect of Low-calorie diet with/without garlic extract supplementation on anthropometric indices and depression status in overweight/obese subjects with major depressive disorder: a clinical trial

Protocol summary

Study aim
Determine the effect of low-calorie diet with and without supplementation with garlic extract on anthropometric indices and depression status in overweight and obese people with major depressive disorder
Design
A clinical trial with a control group (intervention and control group), with parallel groups, double-blind, randomized, sample size of 90 people. Randomization is done using Random-Allocation software.
Settings and conduct
Place of the study: Neurology and Psychiatry Clinic of Farabi Hospital in Kermanshah. The study population: people with mild or moderate depression who are overweight or obese; Type of blinding: double blind for the participants and the analyst; Blinding method: the starch tablet is prepared with the same shape and color as the garlic extract tablet.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to enter the study; being at the age of 20-50 years old; body mass index equal to or greater than 25; no underlying diseases such as diabetes, endocrine disease, cardiopulmonary, liver, kidney and thyroid disease. Exclusion criteria: Being under weight loss diets in the last 6 months; pregnancy; using steroid, hormonal and anti-coagulant drugs (Aspirin, warfarin and heparin, etc.)
Intervention groups
The intervention group will be subjected to a low-calorie diet with garlic supplementation. The control group will be subjected to a low-calorie diet with the use of starch tablets.
Main outcome variables
Weight; amount of adipose tissue; waist circumference; hip circumference; BMI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181111041611N9
Registration date: 2024-08-07, 1403/05/17
Registration timing: prospective

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Mehnoosh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3710 2009
Email address
mehnoosh_samadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Low-calorie diet with/without garlic extract supplementation on anthropometric indices and depression status in overweight/obese subjects with major depressive disorder: a clinical trial
Public title
Effect of low-calorie diet and garlic extract in overweight or obese depressed people
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild or moderate depression who are overweight or obese Cooperation and consent to enter the study Age group 20-50 years Not having underlying diseases such as diabetes, endocrine disease, cardiopulmonary disease, liver disease, kidney disease, and thyroid disease
Exclusion criteria:
Being under weight loss diets in the last 6 months Pregnancy Lactation Taking steroid, hormonal, and anticoagulant drugs (aspirin, warfarin, heparin, etc.) Taking vitamin, mineral or antioxidant supplements
Age
From 20 months old to 50 months old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into intervention and placebo groups based on multi-stage randomization. Based on age and sex, 4 classes are created, in this way, first, patients are divided into two age groups, 20 to 35 years old and 35 to 50 years old, and then in each subgroup of people, they are divided into two groups, male and female. In each gender subgroup, people are assigned to 2 intervention and placebo subgroups based on cluster randomization. The random sequence will be generated using Random-Allocation software, so the participants will not know which group they are in.
Blinding (investigator's opinion)
Double blinded
Blinding description
This clinical trial will be blinded in 2 levels (person participating in the study and person analyzing). In this way, the participants and the analyst do not know how to divide people into supplement and placebo groups. Placebo and garlic extract pills will be completely identical in terms of shape and color. The random sequence will be generated using Random-Allocation software, so the participants will not know which group they are in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
School of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Approval date
2024-06-08, 1403/03/19
Ethics committee reference number
IR.KUMS.REC.1403.108

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified

2

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

Primary outcomes

1

Description
The amount of adipose tissue
Timepoint
The beginning and end of the study (the end of the 12th week of the intervention)
Method of measurement
body analyzer

2

Description
Weight
Timepoint
The beginning and end of the study (the end of the 12th week of the intervention)
Method of measurement
scale

3

Description
Waist circumference
Timepoint
The beginning and end of the study (the end of the 12th week of the intervention)
Method of measurement
tape measure

4

Description
Hip circumference
Timepoint
The beginning and end of the study (the end of the 12th week of the intervention)
Method of measurement
tape measure

5

Description
Body mass index
Timepoint
The beginning and end of the study (the end of the 12th week of the intervention)
Method of measurement
Body analyzer

Secondary outcomes

1

Description
Depression score in Beck questionnaire
Timepoint
Beginning and end of the study (end of 12 weeks of intervention)
Method of measurement
Beck depression questionnaire

Intervention groups

1

Description
Intervention group: They will be placed under a low-calorie diet with the use of garlic supplements, so that the patients will receive 800 mg of dry garlic powder in the form of tablets (equivalent to 2200 micrograms of allicin) in two divided doses with lunch and dinner. The low-calorie diet will be designed in such a way that first the daily calorie requirement of each person is calculated based on his ideal weight and by subtracting 500 kilocalories from that, low-calorie diet for each person separately will be designed. This diet will be 55% of carbohydrates, 15% of protein and 30% of fat. Nutritional recommendations related to the weight loss diet are based on following a healthy food pyramid, including the use of whole grain bread and cereals, separating excess fat of meat , poultry and fish , the use of low-fat dairy products, consumption of more types of vegetables , limiting the consumption of sugar-sweetened beverages , the use of healthy fat sources such as olive oil, and changing the way of cooking and using boiling and steaming methods , etc and tips like this will be given to each person.
Category
Rehabilitation

2

Description
Control group: under a low-calorie diet, they will receive 800 mg of starch daily in the form of 400 mg tablets in two divided doses with lunch and dinner. In this study, based on what was seen in previous studies, starch will be used as a placebo. The low-calorie diet will be designed in such a way that first the daily calorie requirement of each person is calculated based on his ideal weight and by subtracting 500 kilocalories from that, low-calorie diet for each person separately will be designed. This diet will be 55% of carbohydrates, 15% of protein and 30% of fat. Nutritional recommendations related to the weight loss diet are based on following a healthy food pyramid, including the use of whole grain bread and cereals, separating excess fat of meat , poultry and fish , the use of low-fat dairy products, consumption of more types of vegetables , limiting the consumption of sugar-sweetened beverages , the use of healthy fat sources such as olive oil, and changing the way of cooking and using boiling and steaming methods , etc and tips like this will be given to each person.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Samaneh Bozorgi
Street address
Farabi medical education center, next to School of Nutrition Sciences and Food Industry, Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3826 1046
Email
www.hos_farabi@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sirus Jalili
Street address
Research and Technology Vice-Chancellor, No. 2 Medical Sciences building, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3837 1706
Email
mehnoosh_samadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3837 1706
Email
mehnoosh_samadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition Sciences and Food Industry, next to Farabi Hospital, Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3837 1706
Email
mehnoosh_samadi@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
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
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