The effect of black garlic consumption on weight, blood lipid profile/ index and body fat percentage of overweight people receiving low calorie diet- Clinical trial
Determining the effect of black garlic consumption on weight, blood lipid indices and body fat percentage of obese people receiving a low-calorie diet
Design
40 obese people will be selected and randomly assigned into two groups. The intervention group will be given 10 grams of black garlic daily. The control group is asked to refrain from consuming garlic and garlic products.
Settings and conduct
The aim is to investigate the effect of consuming black garlic on the weight and body fat of obese people. Black garlic will be purchased from authorized production establishments.
Among the obese people referred to Shahid Mofteh Yasouj Nutrition Clinic, the eligible people who agree to participate in the study will be selected and randomly assigned to the group receiving the low-calorie diet with or without black garlic. The intervention time is 8 weeks. The project leader and the analyst will be blind to the groups until the end of the analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a body mass index above 25, age above 18 years, agreeing to participate in the project.
Exclusion criteria: history of consuming garlic in the last month, receiving weight-reducing drugs, having diabetes, allergy to garlic, pregnancy, non-compliance with the diet, use of drugs affecting weight, non-referral, non-regular consumption of black garlic in the intervention group and consumption of garlic and its products in the control group
Intervention groups
Intervention: 20 cases with BMI above 25 on a low-calorie diet with daily consumption of 10 grams black garlic.
Control: 20 obese people with body mass index above 25 on a low-calorie diet without consumption of garlic and its products.
Main outcome variables
body weight; body fat percentage; serum total cholesterol; serum triglyceride; serum low-density lipoprotein; Serum high-density lipoprotein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230820059190N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Janmohamad Malekzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 3505
Email address
malekjmd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of black garlic consumption on weight, blood lipid profile/ index and body fat percentage of overweight people receiving low calorie diet- Clinical trial
Public title
Effects of black garlic on weight loss in obese people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No consumption of other garlic products in groups
Not receiving weight-reducing drugs
Not having diabetes and familial hyperlipidemia
No allergy to black garlic
Exclusion criteria:
>30% non-compliance with the diet
Taking drugs that affect weight during treatment
Failure to refer for weight control
Not receiving prescribed garlic orderly
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In case of agreement to participation in the project, the cases will be randomly assigned to one of the two intervention groups (receiving black garlic) and the control group(not receiving black garlic). The randomization method is to generate 20 random numbers from 1 to 40 by Excel software to be assigned to the intervention group and the remaining 20 numbers to be assigned to the control group. Cases will be numbered based on the order of referring and each will be assigned to the relevant group based on the related number. Both groups will be given a proportionate low-calorie diet, and the intervention group will be given 10 grams of black garlic daily in addition to the low-calorie diet. Body weight, body fat percentage and serum lipids (triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol) are measured and compared at the beginning of the intervention and after 8 weeks of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
The project manager and the statistician will not be aware of the given treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari Blvd.,Yasouj University of Medical Sciences., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.YUMS.REC.1402.018
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
Body Weight
Timepoint
At the beginning and two months after therapeutic intervention (low-calorie diet with or without black garlik)
Method of measurement
Accurate scale measuring 0.1 kg
2
Description
Body fat percent
Timepoint
At the beginning and two months after therapeutic intervention (low-calorie diet with or without black garlik)
Method of measurement
Bioimpedance Measurement
Secondary outcomes
1
Description
Serum total cholesterol
Timepoint
At the beginning of the study (Just before the start of the intervention) and 8 weeks after the start of consuming black garlic and a low-calorie diet
Method of measurement
Enzymatic Method
2
Description
Serum triglyceride
Timepoint
At the beginning of the study (Just before the start of the intervention) and 8 weeks after the start of consuming black garlic and a low-calorie diet
Method of measurement
Enzymatic Method
3
Description
Serum high density lipoprotein
Timepoint
At the beginning of the study (Just before the start of the intervention) and 8 weeks after the start of consuming black garlic and a low-calorie diet
Method of measurement
Enzymatic method
4
Description
Serum low density lipoprotein
Timepoint
At the beginning of the study (Just before the start of the intervention) and 8 weeks after the start of consuming black garlic and a low-calorie diet
Method of measurement
Estimating using freidwald formula
Intervention groups
1
Description
Intervention group: The intervention group of 20 people will receive 10 grams of black garlic daily under a low-calorie diet for 8 weeks.
Category
Treatment - Other
2
Description
Control group: The control group will be 20 people who will be on a low-calorie diet without consuming black garlic garlic product.