Status:
COMPLETED
Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborating Sponsors:
US Army Combat Capabilities Development Command- Soldier Center
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Gastrointestinal Injury
Acute Mountain Sickness
Eligibility:
All Genders
17-39 years
Phase:
NA
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) fo...
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...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04111263
Start Date
October 6 2019
End Date
November 5 2022
Last Update
December 23 2022
Active Locations (1)
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1
USARIEM
Natick, Massachusetts, United States, 01760