Quality of LifeNCT06648967
Impact of Different Carbohydrate Feedings on a Hydrogen Breath Curve and Self-reported Gastrointestinal Complaints
A study testing Supplementation with a multi-ingredient whey supplement in people with Quality of Life, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Supplementation with a multi-ingredient whey supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 1 Jul 2026
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydrogen Breath Test Results After Consuming Fructose at Baseline and After Protein Supplementation
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.
Read the detailed description
The present study aims to examine the difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings.
In addition, the study aims to evaluate the difference in hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation.
The objective of the study is to answer following questions:
Question 1: Does treadmill hiking in the heat combined with a glucose-fructose feeding (i.e. ration 2:1 or 1:2) result in different hydrogen breath malabsorption curves and GI symptoms.
Question 2: Is there a difference in hydrogen breath test curves and self-reported gastrointestinal symptom ratings over time, after 3 and 5 weeks of supplementation, when consuming a multi-ingredient whey supplement compared to baseline.
No study procedures will start until informed consent has been obtained.
The familiarization: If participants meet all the inclusion criteria and choose to participate, participants will start with the familiarization to get a better feeling of the type of exercise they need to perform. Participants will perform an "Ebbeling Submax Test", a two-stage walking protocol lasting ~10 minutes. After this VO2max is determined from the steady state heartrate (HR) and speed following the last 4 minutes of the second stage at 5% grade. Steady state HR is defined as over 120 bpm and ±5 bpm range over at least 2 minutes.
Test protocol: The night prior to each exercise test date, the participant will be asked to consume a standardized, low-fiber meal which will be provided to them. After 10pm, participants will be asked not to consume any calorie containing items and to only consume water. Participants will also be asked to avoid exercising the day prior to testing. The day of the test, participants will arrive fasted, and they will perform a 60-minute hiking protocol in a warm environment. The exercise consists of hiking on a treadmill in a warm environment (>30-35°C), while reaching an exercise intensity of 70% ±5 bpm of the subject's HR max (calculated by the Karvonen method as described below). Which is an intensity in which the subject has an elevated breathing frequency but is still able to talk. The treadmill has a 5% incline, and participants will start at a speed informed by their Ebbeling test results, after this each minute the speed will be increased with 0.5 mph until the heartrate reflects the target HR range, in case walking speed is maxed out treadmill incline can be altered as well. Heart rate and speed will be continuously monitored, if speed needs to be adjusted at a later phase during the protocol (because heartrate is not within the targeted HR-range) this will be recorded to allow for exact copying the protocol during the next exercise sessions. The exercise will be divided in 3 blocks of 20 minutes during which the participants work towards reaching their 70% HR max during an 18-minute period, followed with 2 minutes active rest if needed before the next block. The carbohydrate feeding will consist of 3 carbohydrate gels with ~25 grams of carbohydrate with a 2:1 ratio glucose and fructose during, followed by 500 mL water during test 1, and consumption of 25 grams of glucose in 100 mL at the start of test 2 followed by 50 grams of fructose after the test mixed in 400 mL, no food will be provided after the heat stress test, but water can be consumed ad libitum. Heart rate will be monitored using a heart rate monitor attached via chest strap. Monitor will be placed by the participant beneath all clothing with the monitor at chest level (xyphoid process) with guidance from the research team. If the participant requests help, a research team member will assist.
Hydrogen Breath Analysis: Hydrogen measurements will be issued at baseline (-65min), post-exercise (0min), and with 30-min intervals post-exercise at 30/60/90/120/150 and 180 min. Hydrogen breath analysis is a minimally invasive procedure which requires the participant to breath normally but exhale into a gas sample bag until the 250mL bag is filled.
Gastrointestinal Distress: Accompanying the hydrogen breath test at -65min, 0min, 60min, 120min and 180mi, a GSRS questionnaire will also be given. The GSRS consists of 15 items and typically assesses GI complaints in the seven days before survey administration, however, instructions will be modified to request symptoms experienced at the time of administration. The GSRS will be administered digitally in this study and will require less than 5 minutes to complete. The 15 items (1: Upper abdominal pain; 2: Heartburn; 3: Acid reflux; 4: Hunger pains; 5: Nausea; 6: Rumbling in the stomach; 7: Bloated; 8: Burping; 9: Passing gas or flatus; 10: Constipation; 11: Diarrhea; 12: Loose stools; 13: Hard stools; 14: Urgent need to defecate; 15: Incomplete emptying of bowels) assessed the extent of discomforts of GI symptoms based on a 7-point Likert scale, where higher scores reflect more severe discomforts. A total score with no complaints would result in 15 points, whereas the maximal score would result in 105 points.
Baseline testing (exercise test 1 and test 2): Participants will be scheduled for 2 separate test visits including a 60 min hiking test, followed by 3 hours of hydrogen breath data and gastrointestinal symptoms data collection. The two visits set one week apart will be completed. No supplementation between these visits will be consumed and participants will be advised to mimic exercise and diet the day prior to testing. On both visits, participants will arrive fasted and will complete the testing protocol as described below. At the end of the second visit, instructions for the 3-week supplementation will be given to the participants and the product will be sent home with them.
Testing after supplementation (exercise test 3 and test 4): After these baseline visits, a 3-week protein supplementation protocol will be completed followed by again a test visit, followed by an additional 2-week protein supplementation protocol and a final test visit. The commercially available protein supplement (Biotis® Fermentis), is a multi-ingredient fermented whey supplement with 8 g of protein and 4 g of soluble fiber (galactooligosaccharides) per serving.
- Conditions
- Quality of Life
- Being tested
- Supplementation with a multi-ingredient whey supplement
- Keywords
- participants, healthy subjects, women, men, malabsorption syndrome
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with a multi-ingredient whey supplementDietary supplement
Malabsorption of two different fructose boluses at baseline and after 3 and 5 weeks of multi-ingredient whey supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Baseline exercise tests with carbohydrate feeding and after supplementation | Experimental | This arms includes the assessment for difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings during exercise test 1 and 2. In addition, this arm will assess hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation. Receives: Dietary Supplement: Supplementation with a multi-ingredient whey supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen breath curve
Fructose malabsorption will be determined by creating a hydrogen breath curve for each test day.
Measured: Measurements will be taken at -65 min before exercise, directly after exercise at 0 min, and at 30/120/150 and 180 min).
Secondary outcomes (1)
Gastrointestinal symptoms
Gastrointestinal distress (measured through multiple adjusted gastrointestinal symptom rating scale (GSRS) questionnaires).
Measured: Adjusted GSRS (for a 60 min period) will be used to obtain self-reported gastrointestinal distress at -65 min (before exercise), 0 min (directly after exercise), and at 60/120 and 180 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start3 Oct 2024
- Primary completion1 May 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Floris Wardenaar, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648967
- Sponsor's protocol ID
- STUDY00020453
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Breath Test Results After Consuming Fructose at Baseline and After Protein Supplementation
- ClinicalTrials.gov ID
- NCT06648967
- Acronym / sponsor ID
- STUDY00020453
- Conditions
- Quality of Life
- Keywords
- participants, healthy subjects, women, men, malabsorption syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 18 Oct 2024 (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.
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.
Detailed description
The present study aims to examine the difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings.
In addition, the study aims to evaluate the difference in hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation.
The objective of the study is to answer following questions:
Question 1: Does treadmill hiking in the heat combined with a glucose-fructose feeding (i.e. ration 2:1 or 1:2) result in different hydrogen breath malabsorption curves and GI symptoms.
Question 2: Is there a difference in hydrogen breath test curves and self-reported gastrointestinal symptom ratings over time, after 3 and 5 weeks of supplementation, when consuming a multi-ingredient whey supplement compared to baseline.
No study procedures will start until informed consent has been obtained.
The familiarization: If participants meet all the inclusion criteria and choose to participate, participants will start with the familiarization to get a better feeling of the type of exercise they need to perform. Participants will perform an "Ebbeling Submax Test", a two-stage walking protocol lasting ~10 minutes. After this VO2max is determined from the steady state heartrate (HR) and speed following the last 4 minutes of the second stage at 5% grade. Steady state HR is defined as over 120 bpm and ±5 bpm range over at least 2 minutes.
Test protocol: The night prior to each exercise test date, the participant will be asked to consume a standardized, low-fiber meal which will be provided to them. After 10pm, participants will be asked not to consume any calorie containing items and to only consume water. Participants will also be asked to avoid exercising the day prior to testing. The day of the test, participants will arrive fasted, and they will perform a 60-minute hiking protocol in a warm environment. The exercise consists of hiking on a treadmill in a warm environment (>30-35°C), while reaching an exercise intensity of 70% ±5 bpm of the subject's HR max (calculated by the Karvonen method as described below). Which is an intensity in which the subject has an elevated breathing frequency but is still able to talk. The treadmill has a 5% incline, and participants will start at a speed informed by their Ebbeling test results, after this each minute the speed will be increased with 0.5 mph until the heartrate reflects the target HR range, in case walking speed is maxed out treadmill incline can be altered as well. Heart rate and speed will be continuously monitored, if speed needs to be adjusted at a later phase during the protocol (because heartrate is not within the targeted HR-range) this will be recorded to allow for exact copying the protocol during the next exercise sessions. The exercise will be divided in 3 blocks of 20 minutes during which the participants work towards reaching their 70% HR max during an 18-minute period, followed with 2 minutes active rest if needed before the next block. The carbohydrate feeding will consist of 3 carbohydrate gels with ~25 grams of carbohydrate with a 2:1 ratio glucose and fructose during, followed by 500 mL water during test 1, and consumption of 25 grams of glucose in 100 mL at the start of test 2 followed by 50 grams of fructose after the test mixed in 400 mL, no food will be provided after the heat stress test, but water can be consumed ad libitum. Heart rate will be monitored using a heart rate monitor attached via chest strap. Monitor will be placed by the participant beneath all clothing with the monitor at chest level (xyphoid process) with guidance from the research team. If the participant requests help, a research team member will assist.
Hydrogen Breath Analysis: Hydrogen measurements will be issued at baseline (-65min), post-exercise (0min), and with 30-min intervals post-exercise at 30/60/90/120/150 and 180 min. Hydrogen breath analysis is a minimally invasive procedure which requires the participant to breath normally but exhale into a gas sample bag until the 250mL bag is filled.
Gastrointestinal Distress: Accompanying the hydrogen breath test at -65min, 0min, 60min, 120min and 180mi, a GSRS questionnaire will also be given. The GSRS consists of 15 items and typically assesses GI complaints in the seven days before survey administration, however, instructions will be modified to request symptoms experienced at the time of administration. The GSRS will be administered digitally in this study and will require less than 5 minutes to complete. The 15 items (1: Upper abdominal pain; 2: Heartburn; 3: Acid reflux; 4: Hunger pains; 5: Nausea; 6: Rumbling in the stomach; 7: Bloated; 8: Burping; 9: Passing gas or flatus; 10: Constipation; 11: Diarrhea; 12: Loose stools; 13: Hard stools; 14: Urgent need to defecate; 15: Incomplete emptying of bowels) assessed the extent of discomforts of GI symptoms based on a 7-point Likert scale, where higher scores reflect more severe discomforts. A total score with no complaints would result in 15 points, whereas the maximal score would result in 105 points.
Baseline testing (exercise test 1 and test 2): Participants will be scheduled for 2 separate test visits including a 60 min hiking test, followed by 3 hours of hydrogen breath data and gastrointestinal symptoms data collection. The two visits set one week apart will be completed. No supplementation between these visits will be consumed and participants will be advised to mimic exercise and diet the day prior to testing. On both visits, participants will arrive fasted and will complete the testing protocol as described below. At the end of the second visit, instructions for the 3-week supplementation will be given to the participants and the product will be sent home with them.
Testing after supplementation (exercise test 3 and test 4): After these baseline visits, a 3-week protein supplementation protocol will be completed followed by again a test visit, followed by an additional 2-week protein supplementation protocol and a final test visit. The commercially available protein supplement (Biotis® Fermentis), is a multi-ingredient fermented whey supplement with 8 g of protein and 4 g of soluble fiber (galactooligosaccharides) per serving.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline exercise tests with carbohydrate feeding and after supplementation | Experimental | Dietary Supplement: Supplementation with a multi-ingredient whey supplementThis arms includes the assessment for difference between two different boluses of carbohydrate after a hiking test in the heat on fructose malabsorption measured by determining a hydrogen breath curve, as well as taking multiple self-reported gastrointestinal symptom ratings during exercise test 1 and 2. In addition, this arm will assess hydrogen breath response and gastrointestinal symptom ratings (using one of the previously determined carbohydrate boluses) after supplementing a multi-ingredient whey protein for 3 weeks, followed by 2 more weeks of supplementation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- Smoking.
- Clinical or self-perceived lactose intolerance.
- Clinical or self-perceived milk protein allergy.
- Diagnosed GI tract disorders or diseases.
- Musculoskeletal disorders.
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 |
|---|---|---|
| Supplementation with a multi-ingredient whey supplementMalabsorption of two different fructose boluses at baseline and after 3 and 5 weeks of multi-ingredient whey supplementation. | Dietary supplement | Baseline exercise tests with carbohydrate feeding and after supplementation |
Primary outcome
Hydrogen breath curve
Time frame: Measurements will be taken at -65 min before exercise, directly after exercise at 0 min, and at 30/120/150 and 180 min).
Fructose malabsorption will be determined by creating a hydrogen breath curve for each test day.
1 secondary outcome
Gastrointestinal symptoms
Time frame: Adjusted GSRS (for a 60 min period) will be used to obtain self-reported gastrointestinal distress at -65 min (before exercise), 0 min (directly after exercise), and at 60/120 and 180 min.
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 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation with a multi-ingredient whey supplement in people with Quality of Life, run by Arizona State University 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 8 inclusion and 11 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 24 Jul 2026. 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. 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?
Hydrogen breath curve (time frame: Measurements will be taken at -65 min before exercise, directly after exercise at 0 min, and at 30/120/150 and 180 min).). 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 24 Jul 2026.