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IRCT20230820059190N1 IRCT 2023-09-02 Yasouj University of Medical Sciences Effects of black garlic on weight loss in obese people 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 2023-09-23 anticipated 40 Complete https://irct.ir/trial/72181 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: The project manager and the statistician will not be aware of the given treatment. 2-3 obesity. Intervention 1: Intervention group: The intervention group of 20 people will receive 10 grams of black garlic daily under a low-calorie diet for 8 weeks. Intervention 2: Control group: The control group will be 20 people who will be on a low-calorie diet without consuming black garlic garlic product. Yes - There is a plan to make this available What will be shared: Data on primary variables will be shareable after de-identifying individuals When: Just after publishing the paper up to one year after the results are published To whom: The data will only be available to researchers working in academic and scientific institutions and also health related sections Conditions: Data will be allowed to be reanalyzed for use in secondary studies such as meta-analyses Where to obtain: Jan Mohammad Malekzadeh. Yasouj University of Medical Sciences. Faculty of Health and Nutrition Email: malekjmd@yahoo.com How to obtain: After receiving approval from Yasouj University of Medical Sciences (one week to one month), the data will be sent to the applicant Comments:
public Gita Shafiei
15 Imam Hossein Square, Golestan, Faculty of Health and Nutrition
Yasuj Iran (Islamic Republic of) 7591875114 +98 74 3322 5519 shafiei.g71@gmail.com Yasouj University of Medical Sciences scientific Jan Mohammad Malekzadeh
Imam Hossein Square - Golestan 15, Faculty of Health and Nutrition
Yasuj Iran (Islamic Republic of) 7591875114 +98 74 3322 5519 malekjmd@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) No consumption of other garlic products in groups Not receiving weight-reducing drugs Not having diabetes and familial hyperlipidemia No allergy to black garlic 18 years 60 years Both >30% non-compliance with the diet Taking drugs that affect weight during treatment Failure to refer for weight control Not receiving prescribed garlic orderly E66.0 Obesity due to excess calories Treatment - Other Treatment - Other Intervention group: The intervention group of 20 people will receive 10 grams of black garlic daily under a low-calorie diet for 8 weeks. Control group: The control group will be 20 people who will be on a low-calorie diet without consuming black garlic garlic product. 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. 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. 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. 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. 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. 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. Yasouj University of Medical Sciences Approved 2023-03-13 Ethics Committee of Yasuj University of Medical Sciences Shahid Motahari Blvd.,Yasouj University of Medical Sciences., Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)