Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hasanuddin University

Criteria

Inclusion Criteria:

1. Age above 18 years old

2. Not receive antibiotic prescription within the last 6 months

Exclusion Criteria

1. Taking medication that alters the blood sugar

2. Taking probiotic or synbiotic product (such as yogurt)

3. Participant who do not take the synbiotic intervention for more than 3 days consecutively

4. incomplete follow up examination results

5. Develop adverse effect