Gastrointestinal InjuryNCT04111263
Gut-microbiota Targeted Nutritional Intervention for Gut Barrier Integrity at High Altitude
A study testing FP, High altitude and Sea level in people with Gastrointestinal Injury and Acute Mountain Sickness, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Injury, Acute Mountain Sickness
- What is being tested?
- FP, High altitude and Sea level
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2019to 5 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Gut-microbiota Targeted Nutritional Intervention for Promoting Gut Barrier Integrity During Short-term Exposure to Hypobaric Hypoxia.
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.
Read the 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).
- Conditions
- Gastrointestinal Injury, Acute Mountain Sickness
- Being tested
- FP, Placebo, High altitude, Sea level
- Keywords
- Microbiome, Intestinal permeability, Cognition, Immune, Fiber, Military, Altitude, Polyphenol
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPDietary supplement
Fiber and polyphenol blend
PlaceboDietary supplement
Matched placebo
High altitudeOther
Simulated high altitude in altitude chamber using hypobaric hypoxia
Sea levelOther
Sea level environment in altitude chamber
| Study group | Role | What they receive |
|---|---|---|
| PL+SHAM | Sham comparator | Placebo intervention + sea level exposure Receives: Dietary Supplement: Placebo; Other: Sea level |
| PL+HA | Placebo comparator | Placebo intervention + high altitude exposure Receives: Dietary Supplement: Placebo; Other: High altitude |
| FP+HA | Experimental | Fiber and polyphenol supplementation + high altitude exposure Receives: Dietary Supplement: FP; Other: High altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in intestinal permeability
Intestinal permeability measured by the ratio of the urinary excretion of sucralose and erythrirol
Measured: Study days 20, 40 and 60
Secondary outcomes (47)
Difference in lipopolysaccharide binding protein concentrations
Fasting serum lipopolysaccharide binding protein concentration
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in zonulin concentrations
Fasting serum zonulin concentration
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in glucagon-like peptide-2 concentrations
Fasting serum glucagon-like peptide-2 concentration
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in intestinal fatty acid binding protein concentrations
Fasting and post-exercise serum intestinal fatty acid binding protein concentration
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in claudin-3 concentrations
Fasting and post-exercise serum claudin-3 concentration
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in S100B concentrations
Fasting and post-exercise serum S100B concentration
Measured: Study days 20, 21, 41, 42, 62, 63
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
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in intestinal inflammation
Fecal calprotectin concentration
Measured: Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Difference in glucose concentrations
Fasting and post-exercise serum glucose concentrations
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in insulin concentrations
Fasting and post-exercise serum insulin concentrations
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in lactate concentrations
Fasting and post-exercise serum lactate concentrations
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in glycerol concentrations
Fasting and post-exercise serum glycerol concentrations
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in cortisol concentrations
Fasting and post-exercise serum cortisol concentrations
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in bone specific alkaline phosphatase concentrations
Fasting serum bone specific alkaline phosphatase concentration
Measured: Study days 20, 41, 62
Difference in carboxy-terminal collagen crosslinks concentrations
Fasting serum carboxy-terminal collagen crosslinks concentration
Measured: Study days 20, 41, 62
Difference in tartrate resistant acid phosphatase concentrations
Fasting serum tartrate resistant acid phosphatase concentration
Measured: Study days 20, 41, 62
Difference in procollagen type 1 N-terminal propeptide concentrations
Fasting serum procollagen type 1 N-terminal propeptide concentration
Measured: Study days 20, 41, 62
Difference in osteocalcin concentrations
Fasting serum osteocalcin concentration
Measured: Study days 20, 41, 62
Difference in secretory immunoglobulin A concentrations
Secretory immunoglobulin A concentrations in tear fluid and saliva
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in immune cell phenotypes
Immune cell phenotype by flow cytometry
Measured: Study days 21, 42, 63
Difference in T-cell simulated cytokine production
T-cell simulated cytokine production by cell culture and flow cytometry
Measured: Study days 21, 42, 63
Difference in natural killer-cell cytotoxicity
Natural killer-cell cytotoxicity by cell culture and flow cytometry
Measured: Study days 21, 42, 63
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
Measured: Study days 20, 21, 41, 42, 62, 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.
Measured: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
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).
Measured: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
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.
Measured: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
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.
Measured: Study days 20, 21, 41, 42, 62, 63
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)
Measured: Study days 20, 21, 41, 42, 62, 63
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).
Measured: Study days 20, 21, 41, 42, 62, 63
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.
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in risk taking behavior
Measured by Balloon Analogue Risk Task
Measured: Study days 7, 20, 21, 41, 42, 62, 63
Difference in resting metabolic rate
Resting metabolic rate measured by indirect calorimetry
Measured: Study days 7, 21, 42, 63
Difference in physical activity energy expenditure
Energy expenditure measured by indirect calorimetry during 60-minute steady state exercise
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in gastrointestinal transit time
Gastric, small intestine and large intestine transit time measured by SmartPill
Measured: Study days 20, 41, 62
Difference in gastrointestinal pH
Gastric, small intestine and large intestine pH measured by SmartPill
Measured: Study days 20, 41, 62
Difference in changes in working memory
Measured by N-Back task before, during and after exercise
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in changes in spatial working memory
Measured by emotional Interference task before, during and after exercise
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in changes in spatial memory
Measured by Matching to Sample test in the morning and afternoon
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in change in reaction time
Measured by reaction time task before, during and after exercise
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in change in response inhibition
Measured by Go/No-Go task before, during and after exercise
Measured: Study days 20, 21, 41, 42, 62, 63
Difference in vigilance
Measured by scanning visual vigilance task
Measured: Study days 20, 21, 23, 41, 42, 44, 62, 63, 65
Difference in simple visual reaction time
Measured by psychomotor vigilance test
Measured: Study days 20, 21, 23, 41, 42, 44, 62, 63, 65
Difference in language-based logical reasoning
Measured by grammatical Reasoning task
Measured: Study days 20, 21, 23, 41, 42, 44, 62, 63, 65
Difference in ambulatory vigilance
Measured by wrist-worn vigilance monitor
Measured: 48-hours/day during study weeks 0, 2, 3, 5, 6, 8, 9
Difference in fecal short chain fatty acids
Fecal short chain fatty acid concentrations
Measured: Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Difference in gut microbiota composition
Fecal bacterial community diversity and relative abundance measured by 16S rRNA gene sequencing
Measured: Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Differences in microRNA concentrations
Fasting and post-exercise circulating and exosomal microRNA
Measured: Study days 20, 21, 41, 42, 62, 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start6 Oct 2019
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- US Army Combat Capabilities Development Command- Soldier Center, Walter Reed Army Institute of Research (WRAIR), University of Reading
- Responsible party
- Sponsor
- Investigators
- J. Philip Karl, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111263
- Sponsor's protocol ID
- 19-02-HC
- Other IDs
- M-10783
- Status last verified
- Dec 2022
- First submitted
- 2 Jul 2019
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Gut-microbiota Targeted Nutritional Intervention for Promoting Gut Barrier Integrity During Short-term Exposure to Hypobaric Hypoxia.
- ClinicalTrials.gov ID
- NCT04111263
- Acronym / sponsor ID
- 19-02-HC
- Conditions
- Gastrointestinal Injury, Acute Mountain Sickness
- Keywords
- Microbiome, Intestinal permeability, Cognition, Immune, Fiber, Military, Altitude, Polyphenol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- US Army Combat Capabilities Development Command- Soldier Center, Walter Reed Army Institute of Research (WRAIR), University of Reading
- Study start
- 6 Oct 2019 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PL+SHAM | Sham comparator | Dietary Supplement: Placebo, Other: Sea levelPlacebo intervention + sea level exposure |
| PL+HA | Placebo comparator | Dietary Supplement: Placebo, Other: High altitudePlacebo intervention + high altitude exposure |
| FP+HA | Experimental | Dietary Supplement: FP, Other: High altitudeFiber and polyphenol supplementation + high altitude exposure |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (30 listed)
- 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:
- Past GI surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPFiber and polyphenol blend | Dietary supplement | FP+HA |
| PlaceboMatched placebo | Dietary supplement | PL+HA, PL+SHAM |
| High altitudeSimulated high altitude in altitude chamber using hypobaric hypoxia | Other | FP+HA, PL+HA |
| Sea levelSea level environment in altitude chamber | Other | PL+SHAM |
Primary outcome
Difference in intestinal permeability
Time frame: Study days 20, 40 and 60
Intestinal permeability measured by the ratio of the urinary excretion of sucralose and erythrirol
47 secondary outcomes
Difference in lipopolysaccharide binding protein concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in zonulin concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in glucagon-like peptide-2 concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in intestinal fatty acid binding protein concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in claudin-3 concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in S100B concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in systemic inflammation
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in intestinal inflammation
Time frame: Study days 6, 18, 21, 23, 27, 39, 42, 44, 48, 60, 63, 65
Difference in glucose concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in insulin concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in lactate concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in glycerol concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in cortisol concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in bone specific alkaline phosphatase concentrations
Time frame: Study days 20, 41, 62
Difference in carboxy-terminal collagen crosslinks concentrations
Time frame: Study days 20, 41, 62
Difference in tartrate resistant acid phosphatase concentrations
Time frame: Study days 20, 41, 62
Difference in procollagen type 1 N-terminal propeptide concentrations
Time frame: Study days 20, 41, 62
Difference in osteocalcin concentrations
Time frame: Study days 20, 41, 62
Difference in secretory immunoglobulin A concentrations
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in immune cell phenotypes
Time frame: Study days 21, 42, 63
Difference in T-cell simulated cytokine production
Time frame: Study days 21, 42, 63
Difference in natural killer-cell cytotoxicity
Time frame: Study days 21, 42, 63
Difference in development of acute mountain sickness
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in gastrointestinal symptoms; quality of life
Time frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
Difference in gastrointestinal symptoms; irritable bowel syndrome
Time frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
Difference in appetite
Time frame: Study weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9
Difference in changes in mood state
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in changes in feeling
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in changes arousal
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in willingness to take risks
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in risk taking behavior
Time frame: Study days 7, 20, 21, 41, 42, 62, 63
Difference in resting metabolic rate
Time frame: Study days 7, 21, 42, 63
Difference in physical activity energy expenditure
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in gastrointestinal transit time
Time frame: Study days 20, 41, 62
Difference in gastrointestinal pH
Time frame: Study days 20, 41, 62
Difference in changes in working memory
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in changes in spatial working memory
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in changes in spatial memory
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in change in reaction time
Time frame: Study days 20, 21, 41, 42, 62, 63
Difference in change in response inhibition
Time frame: Study days 20, 21, 41, 42, 62, 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Philip Karl, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FP, High altitude and Sea level in people with Gastrointestinal Injury and Acute Mountain Sickness, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in intestinal permeability (time frame: Study days 20, 40 and 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.