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Effect of synbiotic with or without vitamin D on intestinal microbiome

Effect of synbiotic and/or vitamin D on intestinal microbiome and its relationship with muscle strength, function and body composition in overweight or obese middle-aged women.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090822002365N25
Enrollment
88
Registered
2021-03-03
Start date
2021-04-21
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight or obese middle-aged women. Overweight and obesity

Interventions

Intervention 1: Intervention group 1: Receiving one capsule of 50,000 IU of vitamin D (Zahravi company) weekly, along with one capsule of synbiotic placebo containing maltodextrin (Zist takhmir compan

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 55 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad reza Vafa

Iran University of Medical Sciences

vafa.m@iums.ac.ir+98 21 8670 4734

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026