MedTrace Logo

Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity

NCT04642482 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-11-24

No results posted yet for this study

Summary

Background :

There is a plausible relationship between microbial gut and insulin resistance. Intervention to prevent insulin resistance by modifying the microbial gut has been proposed but limited studies demonstrates the expected impact. One of the possible way to manipulate the microbial gut is the administration of synbiotic (prebiotic and probiotic).

Objective :

This study aim to address the impact of synbiotic administration to the microbial gut and insulin resistance.

Brief Methodology :

A Quasi Experimental study with multiple arms is conducted to healthy participants. All subjects will undergo a microbial gut taxonomic analysis using faecal sample and blood examination to determine the insulin resistance status (using Homeostatic Model Assessment for Insulin Resistance/HOMA-IR approach). Synbiotic will be given to intervention arm and active comparator will use maltodextrin. Repeated measurement will be conducted after 8 weeks and 12 weeks from the day of administration.

Hypothesis : A superiority trial hypothesis is applied, assuming that the synbiotic group will demonstrates higher variety of microbial gut and lower HOMA-IR level

Conditions

Interventions

DIETARY_SUPPLEMENT

Synbiotic (Rillus)

Participants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water.

DRUG

Placebo

Participants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water.

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Nasrum Massi, Prof. · Hasanuddin University

  • Andi Anggeraini · Hasanuddin University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2019-12-26
Completion
2020-09-01

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04642482 on ClinicalTrials.gov