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

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Brief Title

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

Official Title

Efficacy of a Gut-microbiota Targeted Nutritional Intervention for Promoting Gut Barrier Integrity During Short-term Exposure to Hypobaric Hypoxia.

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.

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).

Study Type

Interventional

Primary Outcome

Difference in intestinal permeability

Secondary Outcome

 Difference in lipopolysaccharide binding protein concentrations

Condition

Gastrointestinal Injury

Intervention

FP

Study Arms / Comparison Groups

 PL+SHAM
Description:  Placebo intervention + sea level exposure

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Dietary Supplement

Estimated Enrollment

33

Start Date

October 6, 2019

Completion Date

November 5, 2022

Primary Completion Date

November 5, 2022

Eligibility Criteria

        Inclusion criteria:

          -  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

        Exclusion Criteria:

          -  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:

               1. Musculoskeletal injuries that compromise exercise capability

               2. Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes,
                  cardiovascular disease, etc.)

               3. Suspected or known strictures, fistulas, or physiological/mechanical GI
                  obstruction

               4. Evidence of apnea or other sleeping disorders

               5. Evidence of prior high altitude pulmonary or cerebral edema diagnosis

               6. Disease of the GI tract including, but not limited to diverticulitis,
                  inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative
                  colitis

               7. Anemia or Sickle Cell Anemia/Trait

               8. Alcoholism or other substance abuse issues

               9. History of gastric bezoar

              10. Swallowing disorders; severe dysphagia to food or pills

              11. Implanted or portable electro-mechanical medical devices

              12. Allergy to skin adhesive

          -  Past GI surgery

          -  Colonoscopy within 3 months of study participation

          -  Taking prescription medications other than a contraceptive (unless approved by Medical
             Office and study PI)

          -  Regular use of over-the-counter medications (including antacids, laxatives, stool
             softeners, and anti-diarrheals) unless approved by Medical Office and study PI

          -  Any use of antibiotics, except topical antibiotics, within 3 months of study
             participation

          -  Not willing to refrain from using non-steroidal anti-inflammatory medications (NSAIDs)
             or antihistamine during the study

          -  Not willing to stop consumption of prebiotic- or probiotic-containing supplements
             (e.g.,VSL#3, PRO-15, etc.), or other dietary supplements at least 2 weeks before and
             throughout study participation

          -  Not willing to stop consumption of probiotic-containing foods (e.g., yogurt, etc.)
             during study participation.

          -  Not willing to refrain from smoking any nicotine product (includes e-cigarettes),
             vaping, and chewing tobacco during controlled-diet periods.

          -  Not willing to abstain from caffeine and alcohol during controlled-diet periods.

          -  Allergies, intolerances, unwillingness or inability to eat provided foods and
             beverages

          -  Following vegetarian/vegan diet

          -  Unable to regularly sleep for 7-10 hr/night

          -  Any previous blood donation, within 8 weeks of the first blood draw of the study, of a
             volume that when combined with the amount of blood to be collected during the study
             would exceed 550 mL

Gender

All

Ages

17 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

J. Philip Karl, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04111263

Organization ID

19-02-HC

Secondary IDs

M-10783

Responsible Party

Sponsor

Study Sponsor

United States Army Research Institute of Environmental Medicine

Collaborators

 US Army Combat Capabilities Development Command- Soldier Center

Study Sponsor

J. Philip Karl, PhD, Principal Investigator, United States Army Research Institute of Environmental Medicine

Verification Date

December 2022