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

NCT04111263 | Completed

• 2 other identifiers: 19-02-HCM-10783
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiome; Intestinal permeability; Cognition; Immune; Fiber; Military; Altitude; Polyphenol

Outcome Measures

Primary Outcomes (1)

• Difference in intestinal permeability

  Intestinal permeability measured by the ratio of the urinary excretion of sucralose and erythrirol

  Study days 20, 40 and 60

Secondary Outcomes (47)

• Difference in lipopolysaccharide binding protein concentrations

  Study days 20, 21, 41, 42, 62, 63

• Difference in zonulin concentrations

  Study days 20, 21, 41, 42, 62, 63

• Difference in glucagon-like peptide-2 concentrations

  Study days 20, 21, 41, 42, 62, 63

• Difference in intestinal fatty acid binding protein concentrations

  Study days 20, 21, 41, 42, 62, 63

• Difference in claudin-3 concentrations

  Study days 20, 21, 41, 42, 62, 63

Study Arms (3)

PL+SHAM

SHAM COMPARATOR

Placebo intervention + sea level exposure

Dietary Supplement: Placebo; Other: Sea level

PL+HA

PLACEBO COMPARATOR

Placebo intervention + high altitude exposure

Dietary Supplement: Placebo; Other: High altitude

FP+HA

EXPERIMENTAL

Fiber and polyphenol supplementation + high altitude exposure

Dietary Supplement: FP; Other: High altitude

Interventions

FP DIETARY_SUPPLEMENT

Fiber and polyphenol blend

FP+HA

Placebo DIETARY_SUPPLEMENT

Matched placebo

PL+HA; PL+SHAM

High altitude OTHER

Simulated high altitude in altitude chamber using hypobaric hypoxia

FP+HA; PL+HA

Sea level OTHER

Sea level environment in altitude chamber

PL+SHAM

Eligibility Criteria

• Age: 17 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Men and women aged 18 - 39 years (active duty personnel who are 17 yr of age will also be allowed to participate)
• In good health
• Physically active
• For active duty, passed most recent body composition assessment; for civilians, body mass index (BMI) ≤ 30.0 kg/m2.
• Self-reports having a bowel movement at least as frequently as every-other-day
• Self-reports normal vision (with or without glasses) and hearing

You may not qualify if:

• Born at altitudes greater than 2,100 m (\~7,000 feet)
• Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 mo
• Pregnant, expecting to become pregnant during study, or breastfeeding
• Any of the following medical conditions:
• Musculoskeletal injuries that compromise exercise capability
• Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
• Suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
• Evidence of apnea or other sleeping disorders
• Evidence of prior high altitude pulmonary or cerebral edema diagnosis
• Disease of the GI tract including, but not limited to diverticulitis, inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis
• Anemia or Sickle Cell Anemia/Trait
• Alcoholism or other substance abuse issues
• History of gastric bezoar
• Swallowing disorders; severe dysphagia to food or pills
• Implanted or portable electro-mechanical medical devices

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead
• US Army Combat Capabilities Development Command- Soldier Center: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• University of Reading: collaborator

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Sea Level Rise

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oceans and Seas; Geological Phenomena; Physical Phenomena; Climate Change; Climatic Processes; Ecological and Environmental Phenomena; Biological Phenomena; Water Movements

Study Officials

• J. Philip Karl, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: October 1, 2019
• Study Start: October 6, 2019
• Primary Completion: November 5, 2022
• Study Completion: November 5, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)