Effect of synbiotic with or without vitamin D on intestinal microbiome

Phase 2

Conditions: overweight or obese middle-aged women.
Overweight and obesity

Registration Number: IRCT20090822002365N25

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 88

Inclusion Criteria

Overweight and obese women aged 40-55 years
Not being menopaused
Body mass index higher than 25 kg/m2
Willingness to participate in the study

Exclusion Criteria

Vitamin D intake during the last 2-3 months, either orally or by injection
Taking supplements of synbiotics, probiotics and prebiotics during the last 2-3 months
Having chronic diseases such as diabetes, cardiovascular disease, uncontrolled blood pressure, liver and kidney disorders, etc.
Supplements intake containing vitamins, minerals and omega-3 or fish oil
Antibiotic intake during the last three weeks
Following a special diet
Using steroidal and non-steroidal anti-inflammatory drugs, anticonvulsants, anti-cholesterol drugs, antacids, diuretics and and laxatives over the past two months
Using any medications that affect weight over the past two months (such as medications that affect carbohydrate, protein or fat metabolism, and medications that reduce or increase appetite or food intake).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal microbiome. Timepoint: Intestinal microbiome assessment at the beginning of the study and after the intervention (end of week 8). Method of measurement: Real-Time PCR TaqMan method.

Secondary Outcome Measures

Name	Time	Method
Muscle strength. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: handgrip strength and knee extension.;Muscle function. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: TGUG test.;Body composition. Timepoint: At the beginning of the study and after the intervention (end of week 8). Method of measurement: multi-frequency Bioelectrical Impedance Analysis (BIA) and InBody S10 analyzer.