At a glance
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The Effect of Synbiotic on Intestinal Microbiota and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) on Obesity
In Brief
A Phase 4 clinical trial evaluating Synbiotic (Rillus) and Placebo for Obesity and Insulin Resistance. Completed, enrolled 16 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Participants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water.
Participants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water.