Impact of Different Carbohydrate Feedings on a Hydrogen Breath Curve and Self-reported Gastrointe… (NCT06648967) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Different Carbohydrate Feedings on a Hydrogen Breath Curve and Self-reported Gastrointestinal Complaints
United States5 participantsStarted 2024-10-03
Plain-language summary
GI distress is widely prevalent among athletes, ranging from 30 to 90% in recreationally and professionally active athletes. As the recipient of nutrients, the gastrointestinal (GI) tract plays an important role in athleticism. The following pilot project aims to better understand if a fructose load after hiking under heat stress will result in a meaningful hydrogen breath elevation as a marker for malabsorption in healthy participants, and if supplementation of a multi-ingredient fermented whey supplement will result in a different hydrogen breath response rate after a heat stress hiking test.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy subjects living in the United States.
* Women/Men aged between 18-60 years (50-50%).
* BMI value between ≥18.5 and ≤ 30 kg/m2.
* No physical limitations (i.e., able to perform all activities associated with daily living in an independent manner).
* Written informed consent.
* Completed PAR-Q+ without any "yes" responses.
* If currently using chronically or intermittently, willing to stop taking pre- and probiotics beginning 1 month prior to and throughout data collection.
* If currently using chronically or intermittently, willing to stop using laxatives or fiber supplements, antacids and prokinetics beginning 1 month prior to and throughout data collection.
Exclusion Criteria:
* Smoking.
* Clinical or self-perceived lactose intolerance.
* Clinical or self-perceived milk protein allergy.
* Diagnosed GI tract disorders or diseases.
* Musculoskeletal disorders.
* Diagnosed metabolic disorders (such as diabetes).
* Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
* Chronic use of gastric acid suppressing medication or anti-coagulants.
* Chronic use of anti-inflammatory medication.
* Unwilling to stop taking pre- and probiotics beginning 1 month prior to and throughout data collection.
* Unwilling to stop using laxatives or fiber supplements, antacids and prokinetics beginning 1 month prior to and throughout data collection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hydrogen breath curve
Timeframe: Measurements will be taken at -65 min before exercise, directly after exercise at 0 min, and at 30/120/150 and 180 min).