At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)
In Brief
A Phase 2 clinical trial evaluating Sevelamer, Synbiotic, and 3 other interventions for Insulin Sensitivity. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to determine insulin sensitivity in individuals that are lean normal glucose tolerant subjects after consumption of a normal low fat diet and after a high fat diet and to explore the effects of high fat consumption on the intestinal microbiome, and metabolic endotoxemia.( Aim 1 of the protocol, a separate record is available for Aim 2)
Study Details
Timeline
Interventions
1.6 g sevelamer + 4.4 g maltodextrin three times a day
5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.
This is a control group. Maltodextrin, 6 g three times a day
The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.