Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
Condition: Gastrointestinal Injury; Acute Mountain Sickness
MeSH terms: Altitude Sickness
Study type: Interventional

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.
    

Detailed description: 
      The collection of microbes inhabiting the human gastrointestinal (GI) tract, known as the gut
      microbiota, is increasingly recognized as a mediator of GI, immunologic, and neuropsychologic
      responses to various environmental and physiologic stressors. The hypobaric hypoxia
      characteristic of high altitude environments is a stressor that has recently been associated
      with increased GI permeability, and which has been shown to cause decrements in immune,
      neuropsychological and physical function. To what extent modulation of the human gut
      microbiota can mitigate these responses during high altitude exposure is undetermined. 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 in random order.
      Each phase will 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. During one phase the chamber environment will mimic
      low-altitude conditions (SHAM). During two phases the chamber environment will mimic the
      barometric pressure at Pike's Peak CO (460 mmHg; HA).
    

Intervention name(s): FP; Placebo; High altitude; Sea level
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Fiber and polyphenol blend; Matched placebo; Simulated high altitude in altitude chamber using hypobaric hypoxia; Sea level environment in altitude chamber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Microbiome; Intestinal permeability; Cognition; Immune; Fiber; Military; Altitude; Polyphenol