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Study aim
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Determining of the effects of probiotic supplementation on body mass index in overweight and obese adults
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Design
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This is a randomized, controlled double-blind, clinical trial with parallel-group which will be conducted on 74 people with overweghit and obese. Participants are randomly assigned to tow intervention and control groups and each participant is assigned a code.
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Settings and conduct
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74 patient with overweight and obese among people of eligible and referred to private Clinic , Rasht, Iran in the study will be selected.
In this study, patient will be randomly divided into two groups, each will be received supplement or placebo for 12 weeks.37 of patients will be consume 500 mg probiotic and 37 of patients will be consume 500 mg placebo capsules daily. Before the study, containers will be coded as A and B by a person other than the study researchers .
Physical activity information will be collected using short-IPAQ (International Physical Activity Questionnaire) and demographic information through a general information questionnaire. In order to evaluate dietary intake of patients , 24-hr recalls will be completed by interviewing the patient for 3 days (two normal days and a weekend day). Anthropometric indicators will also be measured. All these steps will be completed at the start and end of the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Willingness to cooperate,
Body mass index more than 25 kg/m2,
Age range from 18 to 60 years,
exclusion criteria:
Having acute or chronic metabolic disease,
pregnancy and breastfeeding and Menopause.
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Intervention groups
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Individuals will randomly divided into two groups to receive 500 mg probiotic supplementation or placebo per day for 12 weeks.
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Main outcome variables
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Body mass index, Weight, Waist circumference, Hip circumference, Waist–Hip Ratio, Body fat