Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1)

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 2, 2014

Primary Completion Date

February 23, 2018

Study Completion Date

March 30, 2020

Conditions
Insulin Sensitivity
Interventions
DRUG

Sevelamer

1.6 g sevelamer + 4.4 g maltodextrin three times a day

DRUG

Synbiotic

5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.

DRUG

Maltodextrin

This is a control group. Maltodextrin, 6 g three times a day

OTHER

High Fat diet

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.

OTHER

Low Fat diet

The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.

Trial Locations (1)

78229

Audie L. Murphy VA Hospital, STVHCS, San Antonio

All Listed Sponsors
collaborator

American Diabetes Association

OTHER

lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT02124759 - Mechanism of Microbiome-induced Insulin Resistance in Humans (Aim 1) | Biotech Hunter | Biotech Hunter