Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude

Summary

The aim of this randomized, crossover clinical trial is to determine the efficacy of a gut microbiota-targeted nutritional intervention containing a blend of fermentable fibers and polyphenols (FP) for mitigating increases in GI permeability, and decrements in immune function and neuropsychologic performance following rapid ascent to simulated high altitude. Fifteen healthy young adults will participate in each of three study phases that include a 14-day supplementation period in which participants will consume 1 of 2 supplement bars: placebo (PL, will be consumed during 2 phases) and FP supplementation (will be consumed during one phase only). During the final 2-d of each phase, participants will live in a hypobaric chamber under sea level or high altitude conditions.

Conditions

• Gastrointestinal Injury
• Acute Mountain Sickness

Interventions

DIETARY_SUPPLEMENT

FP

Fiber and polyphenol blend

DIETARY_SUPPLEMENT

Placebo

Matched placebo

OTHER

High altitude

Simulated high altitude in altitude chamber using hypobaric hypoxia

OTHER

Sea level

Sea level environment in altitude chamber

Sponsors & Collaborators

• US Army Combat Capabilities Development Command- Soldier Center

  collaborator UNKNOWN

• Walter Reed Army Institute of Research (WRAIR)

  collaborator FED

• University of Reading

  collaborator OTHER

• United States Army Research Institute of Environmental Medicine

  lead FED

Principal Investigators

• J. Philip Karl, PhD · United States Army Research Institute of Environmental Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

17 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-06

Primary Completion

2022-11-05

Completion

2022-11-05

Countries

• United States

Study Locations