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

NCT02124759 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-15

Study results available
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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)

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.

Sponsors & Collaborators

Principal Investigators

  • Nicolas Musi, MD. · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-02
Primary Completion
2018-02-23
Completion
2020-03-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02124759 on ClinicalTrials.gov