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IRCT20231113060047N1 IRCT 2023-12-05 Ahvaz University of Medical Sciences The effect of synbiotic supplementation on anthropometric indices and appetite level in obese women under weight loss diet The effect of synbiotic supplementation on anthropometric indices and appetite level in obese women under weight loss diet 2023-11-22 anticipated 66 Complete https://irct.ir/trial/73772 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the participants are classified into grade A obesity (34.9-30) and grade 2 obesity (34.9-39.9) by stratified blocked randomization method and based on body mass index. One of the groups receiving the probiotic supplement or the placebo group is assigned. To randomly assign people to two groups, Stratified Blocked Randomization is used and randomization is done separately within each group. The size of the blocks is in the form of 4, where two allocations to the intervention group (A) and two allocations to the placebo group (B) are considered. that 6 different permutations AABB, ABAB, BBAA, BABA, ABBA, and BAAB will be created, Blinding description: The study will be double-blind, so the researcher and the participants will not know which group they belong to. For blinding, intervention and placebo capsules are presented in similar shapes, colors, and sizes. These capsules are coded by someone other than researchers and then the capsules are given to the participants. Until the end of the study and after analyzing the data, the researchers will not know about the intervention and control groups. 3 obesity. Intervention 1: Intervention group: In this group of people, for 12 weeks, 2 capsules of Synbiotic Femilact Bio Fermentation Co., which contains Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei, Bifidobacterium Brue, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus (CFU blend 109) ) will receive. Intervention 2: Control group: Control group: In this group, people will receive a placebo (containing lactose monohydrate, talc, magnesium stearate, maltodextrin, silicon dioxide, microcrystalline cellulose, sodium starch glycolate) for 12 weeks, which looks like a synbiotic supplement. Yes - There is a plan to make this available What will be shared: The effect of synbiotic supplementation on anthropometric indices and appetite level in obese women under weight loss diet When: After the publication of the article To whom: all people Conditions: study Where to obtain: Dr Ahmad Zare Javid How to obtain: send mail Comments:
public Fateme Pakbaz
Golestan Medical Sciences Dormitory, Golestan Boulevard, Ahvaz, Khuzestan, Iran.
Ahvaz Iran (Islamic Republic of) 6135815751 +98 61 5332 6898 fatemepakbaz76@gmail.com Ahvaz University of Medical Sciences scientific Ahmad Zare Javid
Department of Nutrition, Golestan Boulevard, Golestan, Jundishapur University of Medical Sciences, Ahvaz - Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 5332 6898 zarejavid-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Body mass index between 30 and 39.99 kg/m2 Willingness to cooperate Female gender Stable weight in the last three months Being in the age range of 30 to 50 years 30 years 50 years Female Pregnancy, breastfeeding and menopause Use of any type of antibiotic in the last 3 weeks Use of weight loss and appetite suppressants Suffering from cancer, cardiovascular disease, diabetes, acute gastrointestinal diseases, infectious diseases, chronic kidney and liver diseases except non-alcoholic fatty liver disease Using any type of food supplement and probiotic products Unwillingness to continue cooperation Death Failure to comply with the intervention (use of less than 90% of supplements) Allergic reaction to Yari supplement E66 Overweight and obesity Treatment - Drugs Placebo Intervention group: In this group of people, for 12 weeks, 2 capsules of Synbiotic Femilact Bio Fermentation Co., which contains Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei, Bifidobacterium Brue, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus (CFU blend 109) ) will receive. Control group: Control group: In this group, people will receive a placebo (containing lactose monohydrate, talc, magnesium stearate, maltodextrin, silicon dioxide, microcrystalline cellulose, sodium starch glycolate) for 12 weeks, which looks like a synbiotic supplement. Body Mass Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Height with the help of a calibrated meter with an accuracy of 0.5 cm, which is connected to the wall at a distance of one meter from the ground level, in such a way that the person is completely attached to the wall from the back, both feet are placed together, and the head is along the ground level and looking The person will be measured straight ahead. People's weight will be measured with the help of a Seka digital scale with an accuracy of 0.5 kg with the lightest clothes and bare feet. The body mass index will also be obtained with the help of placing the value of height and weight in the formula. Waist circumference. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: The circumference of the waist will be measured with the help of a graduated meter with a measurement accuracy of 0.5 cm. Hip Circumference. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Hip circumference will be measured with the help of a graduated meter with a measurement accuracy of 0.5 cm. Waist-Hip Ratio. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Waist circumference divided by hip circumference. Fat Mass. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Body fat will be measured by bioelectrical impedance analysis using inbody x-contact 356 made in South Korea. Appetite. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: In order to check the state of appetite, the subjects will be asked to indicate the level of appetite, satisfaction and willingness to eat by marking a position along a continuous line between 0 and 100 mm. Fat Free Mass. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Fat free mass will be measured by bioelectrical impedance analysis using inbody x-contact 356 made in South Korea. A Body Shape Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Body shape index is calculated through waist circumference, height and body mass. Body Adiposity Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: An index to estimate body fat, which is calculated using hip circumference and height. Abdominal Volume Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: An index to estimate abdominal fat, which is used to calculate waist circumference and hip circumference. Conicity Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: An index measuring central obesity, which is used to calculate waist circumference, height, and weight. Weight-adjusted-Waist Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: An innovative measure to measure obesity is the result of dividing the waist circumference by the square root of weight. Waist to Height Ratio. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Waist size divided by height. Body Roudness Index. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: An index to predict body fat and the percentage of visceral fat tissue, which is used to calculate it from height and waist circumference. Diet intake (energy, carbohydrates, fat, protein). Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: Using Nutritionist IV software. Physical activity. Timepoint: The beginning of the intervention, week 6 and week 12. Method of measurement: International Physical Activity Questionnaire. Jundishapur University of Medical Sciences, Ahvaz Approved 2023-11-06 Ethics Committee of Jundishapur Ahvaz University, Ahvaz, Iran ​ 132 / 5,000 Translation results Translation result Academic City - Ahvaz University of Medical Sciences and Health Services - Research and Technology Development Deputy Building - Nutrition and Metabolic Diseases Research Center AHVAZ Khouzestan Iran (Islamic Republic of)