Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
Primary Purpose
Gastrointestinal Injury, Acute Mountain Sickness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FP
Placebo
High altitude
Sea level
Sponsored by
About this trial
This is an interventional prevention trial for Gastrointestinal Injury focused on measuring Microbiome, Intestinal permeability, Cognition, Immune, Fiber, Military, Altitude, Polyphenol
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:
- 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
Sites / Locations
- USARIEM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Placebo Comparator
Experimental
Arm Label
PL+SHAM
PL+HA
FP+HA
Arm Description
Placebo intervention + sea level exposure
Placebo intervention + high altitude exposure
Fiber and polyphenol supplementation + high altitude exposure
Outcomes
Primary Outcome Measures
Difference in intestinal permeability
Intestinal permeability measured by the ratio of the urinary excretion of sucralose and erythrirol
Secondary Outcome Measures
Difference in lipopolysaccharide binding protein concentrations
Fasting serum lipopolysaccharide binding protein concentration
Difference in zonulin concentrations
Fasting serum zonulin concentration
Difference in glucagon-like peptide-2 concentrations
Fasting serum glucagon-like peptide-2 concentration
Difference in intestinal fatty acid binding protein concentrations
Fasting and post-exercise serum intestinal fatty acid binding protein concentration
Difference in claudin-3 concentrations
Fasting and post-exercise serum claudin-3 concentration
Difference in S100B concentrations
Fasting and post-exercise serum S100B concentration
Difference in systemic inflammation
Fasting serum interleukin (IL) IL-6, IL-8, IL-10, IL-17, IL-1β, IL-1ra, tumor necrosis factor-α, interferon-γ concentrations
Difference in intestinal inflammation
Fecal calprotectin concentration
Difference in glucose concentrations
Fasting and post-exercise serum glucose concentrations
Difference in insulin concentrations
Fasting and post-exercise serum insulin concentrations
Difference in lactate concentrations
Fasting and post-exercise serum lactate concentrations
Difference in glycerol concentrations
Fasting and post-exercise serum glycerol concentrations
Difference in cortisol concentrations
Fasting and post-exercise serum cortisol concentrations
Difference in bone specific alkaline phosphatase concentrations
Fasting serum bone specific alkaline phosphatase concentration
Difference in carboxy-terminal collagen crosslinks concentrations
Fasting serum carboxy-terminal collagen crosslinks concentration
Difference in tartrate resistant acid phosphatase concentrations
Fasting serum tartrate resistant acid phosphatase concentration
Difference in procollagen type 1 N-terminal propeptide concentrations
Fasting serum procollagen type 1 N-terminal propeptide concentration
Difference in osteocalcin concentrations
Fasting serum osteocalcin concentration
Difference in secretory immunoglobulin A concentrations
Secretory immunoglobulin A concentrations in tear fluid and saliva
Difference in immune cell phenotypes
Immune cell phenotype by flow cytometry
Difference in T-cell simulated cytokine production
T-cell simulated cytokine production by cell culture and flow cytometry
Difference in natural killer-cell cytotoxicity
Natural killer-cell cytotoxicity by cell culture and flow cytometry
Difference in development of acute mountain sickness
Environmental Symptoms Questionnaire-short form. Acute Mountain Sickness will be measured multiple times daily using the Lake Louise scoring system wherein higher scores indicate more severe symptoms. AMS severity cutoffs will use mild (0.7-1.53), moderate (1.53-2.63), severe >=2.63
Difference in gastrointestinal symptoms; quality of life
Gastrointestinal symptoms measure by modified version of the gastrointestinal quality of life index wherein lower scores indicate more severe symptoms.
Difference in gastrointestinal symptoms; irritable bowel syndrome
Gastrointestinal symptoms measure by modified version of the irritable bowel syndrome symptom severity scale score wherein higher scores indicate more severe symptoms. Scored on scale of 0-500; symptom severity scored as mild (75-174), moderate (175-300), severe (>300).
Difference in appetite
Hunger, fullness, desire to eat, and prospective consumption measured by 100 mm visual analog scale. Scored from 0-100 with higher scores indicating greater sensation.
Difference in changes in mood state
Measured by Profile of Mood States Questionnaire; a 65-item inventory of self-reported mood states which factor into six mood sub-scales (tension/anxiety (0-36), depression/dejection (0-60), anger/hostility (0-48), vigor/activity (0-32), fatigue/inertia (0-28), confusion/bewilderment (0-28), and total mood disturbance (0-200) wherein higher scores indicate greater mood state.
Difference in changes in feeling
Measured by Feeling Scale; a one-item inventory measuring the extent to which participants feel pleasant or unpleasant. Higher scores indicate more unpleasant feeling. Scored from -5 (very bad) to 5 (very good)
Difference in changes arousal
Measured by Felt Arousal Scale; a one-item inventory measuring the extent to which participants feel aroused. Higher scores indicate greater arousal (low=1 to high =6).
Difference in willingness to take risks
Measured by Evaluation of Risks Questionnaire; a 24-item questionnaire providing scores on five scales: self-control, danger seeking, energy, impulsivity, and invincibility.
Difference in risk taking behavior
Measured by Balloon Analogue Risk Task
Difference in resting metabolic rate
Resting metabolic rate measured by indirect calorimetry
Difference in physical activity energy expenditure
Energy expenditure measured by indirect calorimetry during 60-minute steady state exercise
Difference in gastrointestinal transit time
Gastric, small intestine and large intestine transit time measured by SmartPill
Difference in gastrointestinal pH
Gastric, small intestine and large intestine pH measured by SmartPill
Difference in changes in working memory
Measured by N-Back task before, during and after exercise
Difference in changes in spatial working memory
Measured by emotional Interference task before, during and after exercise
Difference in changes in spatial memory
Measured by Matching to Sample test in the morning and afternoon
Difference in change in reaction time
Measured by reaction time task before, during and after exercise
Difference in change in response inhibition
Measured by Go/No-Go task before, during and after exercise
Difference in vigilance
Measured by scanning visual vigilance task
Difference in simple visual reaction time
Measured by psychomotor vigilance test
Difference in language-based logical reasoning
Measured by grammatical Reasoning task
Difference in ambulatory vigilance
Measured by wrist-worn vigilance monitor
Difference in fecal short chain fatty acids
Fecal short chain fatty acid concentrations
Difference in gut microbiota composition
Fecal bacterial community diversity and relative abundance measured by 16S rRNA gene sequencing
Differences in microRNA concentrations
Fasting and post-exercise circulating and exosomal microRNA
Full Information
NCT ID
NCT04111263
First Posted
July 2, 2019
Last Updated
December 20, 2022
Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
US Army Combat Capabilities Development Command- Soldier Center, Walter Reed Army Institute of Research (WRAIR), University of Reading
1. Study Identification
Unique Protocol Identification Number
NCT04111263
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2019 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
November 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
US Army Combat Capabilities Development Command- Soldier Center, Walter Reed Army Institute of Research (WRAIR), University of Reading
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Injury, Acute Mountain Sickness
Keywords
Microbiome, Intestinal permeability, Cognition, Immune, Fiber, Military, Altitude, Polyphenol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PL+SHAM
Arm Type
Sham Comparator
Arm Description
Placebo intervention + sea level exposure
Arm Title
PL+HA
Arm Type
Placebo Comparator
Arm Description
Placebo intervention + high altitude exposure
Arm Title
FP+HA
Arm Type
Experimental
Arm Description
Fiber and polyphenol supplementation + high altitude exposure
Intervention Type
Dietary Supplement
Intervention Name(s)
FP
Intervention Description
Fiber and polyphenol blend
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Matched placebo
Intervention Type
Other
Intervention Name(s)
High altitude
Intervention Description
Simulated high altitude in altitude chamber using hypobaric hypoxia
Intervention Type
Other
Intervention Name(s)
Sea level
Intervention Description
Sea level environment in altitude chamber
Primary Outcome Measure Information:
Title
Difference in intestinal permeability
Description
Intestinal permeability measured by the ratio of the urinary excretion of sucralose and erythrirol
Time Frame
Study days 20, 40 and 60
Secondary Outcome Measure Information:
Title
Difference in lipopolysaccharide binding protein concentrations
Description
Fasting serum lipopolysaccharide binding protein concentration
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in zonulin concentrations
Description
Fasting serum zonulin concentration
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in glucagon-like peptide-2 concentrations
Description
Fasting serum glucagon-like peptide-2 concentration
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in intestinal fatty acid binding protein concentrations
Description
Fasting and post-exercise serum intestinal fatty acid binding protein concentration
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in claudin-3 concentrations
Description
Fasting and post-exercise serum claudin-3 concentration
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in S100B concentrations
Description
Fasting and post-exercise serum S100B concentration
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in systemic inflammation
Description
Fasting serum interleukin (IL) IL-6, IL-8, IL-10, IL-17, IL-1β, IL-1ra, tumor necrosis factor-α, interferon-γ concentrations
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in intestinal inflammation
Description
Fecal calprotectin concentration
Time Frame
Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Title
Difference in glucose concentrations
Description
Fasting and post-exercise serum glucose concentrations
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in insulin concentrations
Description
Fasting and post-exercise serum insulin concentrations
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in lactate concentrations
Description
Fasting and post-exercise serum lactate concentrations
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in glycerol concentrations
Description
Fasting and post-exercise serum glycerol concentrations
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in cortisol concentrations
Description
Fasting and post-exercise serum cortisol concentrations
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in bone specific alkaline phosphatase concentrations
Description
Fasting serum bone specific alkaline phosphatase concentration
Time Frame
Study days 20, 41, 62
Title
Difference in carboxy-terminal collagen crosslinks concentrations
Description
Fasting serum carboxy-terminal collagen crosslinks concentration
Time Frame
Study days 20, 41, 62
Title
Difference in tartrate resistant acid phosphatase concentrations
Description
Fasting serum tartrate resistant acid phosphatase concentration
Time Frame
Study days 20, 41, 62
Title
Difference in procollagen type 1 N-terminal propeptide concentrations
Description
Fasting serum procollagen type 1 N-terminal propeptide concentration
Time Frame
Study days 20, 41, 62
Title
Difference in osteocalcin concentrations
Description
Fasting serum osteocalcin concentration
Time Frame
Study days 20, 41, 62
Title
Difference in secretory immunoglobulin A concentrations
Description
Secretory immunoglobulin A concentrations in tear fluid and saliva
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in immune cell phenotypes
Description
Immune cell phenotype by flow cytometry
Time Frame
Study days 21, 42, 63
Title
Difference in T-cell simulated cytokine production
Description
T-cell simulated cytokine production by cell culture and flow cytometry
Time Frame
Study days 21, 42, 63
Title
Difference in natural killer-cell cytotoxicity
Description
Natural killer-cell cytotoxicity by cell culture and flow cytometry
Time Frame
Study days 21, 42, 63
Title
Difference in development of acute mountain sickness
Description
Environmental Symptoms Questionnaire-short form. Acute Mountain Sickness will be measured multiple times daily using the Lake Louise scoring system wherein higher scores indicate more severe symptoms. AMS severity cutoffs will use mild (0.7-1.53), moderate (1.53-2.63), severe >=2.63
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in gastrointestinal symptoms; quality of life
Description
Gastrointestinal symptoms measure by modified version of the gastrointestinal quality of life index wherein lower scores indicate more severe symptoms.
Time Frame
Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
Title
Difference in gastrointestinal symptoms; irritable bowel syndrome
Description
Gastrointestinal symptoms measure by modified version of the irritable bowel syndrome symptom severity scale score wherein higher scores indicate more severe symptoms. Scored on scale of 0-500; symptom severity scored as mild (75-174), moderate (175-300), severe (>300).
Time Frame
Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
Title
Difference in appetite
Description
Hunger, fullness, desire to eat, and prospective consumption measured by 100 mm visual analog scale. Scored from 0-100 with higher scores indicating greater sensation.
Time Frame
Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
Title
Difference in changes in mood state
Description
Measured by Profile of Mood States Questionnaire; a 65-item inventory of self-reported mood states which factor into six mood sub-scales (tension/anxiety (0-36), depression/dejection (0-60), anger/hostility (0-48), vigor/activity (0-32), fatigue/inertia (0-28), confusion/bewilderment (0-28), and total mood disturbance (0-200) wherein higher scores indicate greater mood state.
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in changes in feeling
Description
Measured by Feeling Scale; a one-item inventory measuring the extent to which participants feel pleasant or unpleasant. Higher scores indicate more unpleasant feeling. Scored from -5 (very bad) to 5 (very good)
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in changes arousal
Description
Measured by Felt Arousal Scale; a one-item inventory measuring the extent to which participants feel aroused. Higher scores indicate greater arousal (low=1 to high =6).
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in willingness to take risks
Description
Measured by Evaluation of Risks Questionnaire; a 24-item questionnaire providing scores on five scales: self-control, danger seeking, energy, impulsivity, and invincibility.
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in risk taking behavior
Description
Measured by Balloon Analogue Risk Task
Time Frame
Study days 7, 20, 21, 41, 42, 62, 63
Title
Difference in resting metabolic rate
Description
Resting metabolic rate measured by indirect calorimetry
Time Frame
Study days 7, 21, 42, 63
Title
Difference in physical activity energy expenditure
Description
Energy expenditure measured by indirect calorimetry during 60-minute steady state exercise
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in gastrointestinal transit time
Description
Gastric, small intestine and large intestine transit time measured by SmartPill
Time Frame
Study days 20, 41, 62
Title
Difference in gastrointestinal pH
Description
Gastric, small intestine and large intestine pH measured by SmartPill
Time Frame
Study days 20, 41, 62
Title
Difference in changes in working memory
Description
Measured by N-Back task before, during and after exercise
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in changes in spatial working memory
Description
Measured by emotional Interference task before, during and after exercise
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in changes in spatial memory
Description
Measured by Matching to Sample test in the morning and afternoon
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in change in reaction time
Description
Measured by reaction time task before, during and after exercise
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in change in response inhibition
Description
Measured by Go/No-Go task before, during and after exercise
Time Frame
Study days 20, 21, 41, 42, 62, 63
Title
Difference in vigilance
Description
Measured by scanning visual vigilance task
Time Frame
Study days 20, 21, 23, 41, 42, 44, 62, 63, 65
Title
Difference in simple visual reaction time
Description
Measured by psychomotor vigilance test
Time Frame
Study days 20, 21, 23, 41, 42, 44, 62, 63, 65
Title
Difference in language-based logical reasoning
Description
Measured by grammatical Reasoning task
Time Frame
Study days 20, 21, 23, 41, 42, 44, 62, 63, 65
Title
Difference in ambulatory vigilance
Description
Measured by wrist-worn vigilance monitor
Time Frame
48-hours/day during study weeks 0, 2, 3, 5, 6, 8, 9
Title
Difference in fecal short chain fatty acids
Description
Fecal short chain fatty acid concentrations
Time Frame
Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Title
Difference in gut microbiota composition
Description
Fecal bacterial community diversity and relative abundance measured by 16S rRNA gene sequencing
Time Frame
Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Title
Differences in microRNA concentrations
Description
Fasting and post-exercise circulating and exosomal microRNA
Time Frame
Study days 20, 21, 41, 42, 62, 63
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Philip Karl, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
USARIEM
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
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