]>
IRCT20220608055106N1 IRCT 2022-07-03 Karaj University of Medical Sciences Effect of probiotics supplementation in the control of obesity The effect of supplementation with Lactobacillus rhamnosus, Lactobacillus fermentum, and Lactobacillus plantarum on anthropometric indices, appetite, and serum level of Nesfatin, Omentin-1, LPS, liver function markers, metabolic parameters, oxidative stress, and inflammatory biomarkers in obese individuals: a triple blinded RCT 2022-07-23 anticipated 100 Complete https://irct.ir/trial/64062 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method with non-matched block size will be studied. For this purpose, a list of the order of allocation of samples by the second (non-original) researcher and using the software provided on the website https://www.sealedenvelope.com. Prepared and the size of the blocks will be two, four and six, Blinding description: After randomization, intervention groups 1 to 3 received powdered sachets containing isolated probiotics Lactobacillus rhamnus, fermentum, and plantarum, respectively, and group 4 received sachets containing maltodextrin as 1 sachet daily before the meal for 60 days. Sachets related to each group were prepared in similar and same-colored packages and provided to them monthly. For further blinding, the packaging of supplements and their coding (A-D) were done by someone outside of the project and other than the main researchers. The patient, doctors, statistical analyst, and the main researcher did not know those codes. After completing the study, the codes will be decoded. 3 Overweight and obesity. Intervention 1: Intervention group: (group1) Probiotic supplement in powder sacs containing Lactobacillus fermentum 014 NIMBB (NCBI MT registration code 994667) isolated from the ridge (for 60 days). Intervention 2: Intervention group:(Group2) Lactobacillus rhamnosus NIMBB006 (NCBI MT registration code 995144) isolated from breast milk at a rate of 2 * 10 cfu (for 60 days). Intervention 3: Intervention group ( Group3) Lactobacillus plantarum isolated from camel milk (cfu 9 10 * 2 NCBI MT 012188)(for 60 days). Intervention 4: Control group: Placebo with tasteless maltodextrin 100 for 60 days(for 60 days). Yes - There is a plan to make this available What will be shared: results publication When: After publishing the articles To whom: Researchers Conditions: with permission of the responsible members of the project Where to obtain: Dr. Vahideh Ebrahimzadeh Attari, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, ebrahimzadeh.va@gmail.com How to obtain: please send an Email to: ebrahimzadeh.va@gmail.com Comments:
public Jamileh Ghalami
Unit 6, No.13, 13 West Ave., Vahdat Town
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3664 8761 s_ghalami@yahoo.com Karaj University of Medical Sciences scientific Vahideh Ebrahimzadeh Attari
Tabriz university of Medical Sciences, Faculty of nutrition, Attar Neyshaboori avenue,
Tabriz Iran (Islamic Republic of) 516665931 +98 41 3335 7581 ebrahimzadeh.va@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Obese people in the range of body mass index( 30≤BMI ≤ 40) Age group of 18-60 years Volunteers 18 years 60 years Both Allergy to probiotics Having Diabetes, kidney disease, liver disease, Thyroid disorders Having a special diet to treat obesity in the last three months Taking corticosteroids and/ or antibiotics Regular Consumption of probiotics and/or nutritional supplements Gastric surgery Pregnancy. lactation Smoking and or drinking alcohol E66 Overweight and obesity Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: (group1) Probiotic supplement in powder sacs containing Lactobacillus fermentum 014 NIMBB (NCBI MT registration code 994667) isolated from the ridge (for 60 days) Intervention group:(Group2) Lactobacillus rhamnosus NIMBB006 (NCBI MT registration code 995144) isolated from breast milk at a rate of 2 * 10 cfu (for 60 days) Intervention group ( Group3) Lactobacillus plantarum isolated from camel milk (cfu 9 10 * 2 NCBI MT 012188)(for 60 days) Control group: Placebo with tasteless maltodextrin 100 for 60 days(for 60 days) Anthropometric indicators (height, weight, BMI, waist circumference). Timepoint: At first and end of two months intervention. Method of measurement: Weight scale, Meter. Novel anthropometric indexes e.g., ABSI, BRI). Timepoint: Weight scale, Meter. Method of measurement: Weight scale, Meter, related formula. Appetite. Timepoint: At first and end of two months intervention. Method of measurement: questionnaire. Serum level of Nesfatin. Timepoint: At first and end of two months intervention. Method of measurement: Elisa kit. Serum level of Omentin-1. Timepoint: At first and end of two months intervention. Method of measurement: Elisa kit. Serum level of LPS. Timepoint: At first and end of two months intervention. Method of measurement: Elisa kit. Liver function test (ALT, AST, ALP). Timepoint: At first and end of two months intervention. Method of measurement: Auto-analyzer based on the principle of photometry. FBS. Timepoint: At first and end of two months intervention. Method of measurement: Auto-analyzer based on the principle of photometry. Serum Insulin. Timepoint: At first and end of two months intervention. Method of measurement: Elisa kit. Lipid profile ( TC, TG, LDL.C, HDL.C). Timepoint: At first and end of two months intervention. Method of measurement: Auto-analyzer based on the principle of photometry. MDA. Timepoint: At first and end of two months intervention. Method of measurement: Spectrophotometer. TAC. Timepoint: At first and end of two months intervention. Method of measurement: Elisa kit. TOC. Timepoint: At first and end of two months intervention. Method of measurement: Elisa kit. CRP. Timepoint: At first and end of two months intervention. Method of measurement: photometry. IL-6. Timepoint: At first and end of two months intervention. Method of measurement: ELISA KIT. IL-1 B. Timepoint: At first and end of two months intervention. Method of measurement: ELISA KIT. TNF alfa. Timepoint: At first and end of two months intervention. Method of measurement: ELISA KIT. Blood urea nitrogen. Timepoint: At first and end of two months intervention. Method of measurement: autoanalyzer. CREATININ. Timepoint: At first and end of two months intervention. Method of measurement: autoanalyzer. Tabriz University of Medical Sciences Karaj University of Medical Sciences Tabriz University of Medical Sciences Approved 2022-05-21 Ethics committee of Alborz University of Medical Sciences Ethics committee unit,Vice Chancellor for Research, No.20, Saffarian alley, 45 Metri Golshahr street Karaj Alborz Iran (Islamic Republic of) Approved 2024-07-08 Ethics committee of Tabriz University of Medical Sciences Golgasht, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of) Approved 2024-08-05 Ethics committee of Tabriz University of Medical Sciences Golgasht, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of) Approved 2024-08-05 Ethics committee of Tabriz University of Medical Sciences Golgasht, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)