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The effect of intermittent fasting combined with synbiotic supplementation on the gut microbiome

The effect of intermittent fasting combined with synbiotic supplementation on the gut microbiome and some obesity-related indicators in people with metabolic syndrome : A single blind Randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250518065785N1
Enrollment
100
Registered
2025-05-21
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

metabolic syndrome. Metabolic syndrome

Interventions

Intervention 1: First intervention group: Synbiotic recipients who receive two synbiotic supplements daily for 8 weeks. The synbiotic consumed is the FamiLact2plus supplement from Zist-Takhmir Company

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: Adults With a diagnosis of metabolic syndrome

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Diversity, composition of gut microbiota in stool samples (using Shannon index to estimate alpha diversity; and using UniFrac index (Unweighted and Weighted) to obtain Beta Diversity) ABSI was also measured as an index that combines information on waist circumference, weight, and height, and higher values ??indicate that the person has a higher waist circumference in relation to his height and weight and are associated with higher abdominal obesity. On the other hand, ABSI is a complementary index to BMI for assessing the risk of chronic diseases and a more suitable index than other anthropometric methods for predicting mortality. In general, anthropometric data, including weight (with an accuracy of 100 grams), height, and waist and hip circumference (using a non-elastic tape measure with an accuracy of 1 mm) were measured using standard methods. The WHR index was obtained by dividing the waist circumference by the hip circumference. The A Body Shape Index was calculated based on the following formula: ABSI = The following formulas were used to calculate the LAP and VAI factors: LAP = WC-65 * TG, in males LAP = WC-58 * TG, in females VAI= (WC/39.68 + 1.88 * BMI) *(TG/1.03) *(1.31/HDL), in males VAI= (WC/36.58 + 1.89 * BMI) *(TG/0.81) *(1.52/HDL), in females. Timepoint: Before and after the intervention (at the beginning and two months later). Method of measurement: Fecal microbiome sequencing DNA isolation and microbiome sequencing of fecal samples will be performed using Realtime PCR technique. Fecal microbiome analysis Diversity criteria include: Alpha diversity: richness (number of species) and evenness (distribution of species) will be assessed using indices such as Shannon index and Simpson index. Beta diversity: relationships between different samples will be analyzed using molecular analysis of variance (PCoA) and AMOVA will be used. Composition criteria Firmicutes-to-Bacteroidetes Ratio (F/B Ratio) will be

Secondary

MeasureTime frame
Plasma levels of gut-derived metabolites (e.g., SCFAs, TMAO). Measurement of metabolic factors will be used to assess the functional capacity of the gut microbiota. Metabolic analyses include short-chain fatty acids (SCFAs): butyrate, acetate, propionate. Trimethylamine-N-oxide (TMAO): associated with cardiovascular risk. and lipopolysaccharide (LPS): a marker of intestinal permeability and inflammation. Timepoint: Before and two months later. Method of measurement: Stool and blood samples will be collected at baseline and after 8 weeks. Samples will be processed and stored at -80°C until analysis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMotahareh Hasani

Gorgan University of Medical Sciences

hasanimotahare@yahoo.com+98 17 3245 6107

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026