Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
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