Anomalies GastrointestinalNCT03596788
Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running
A study testing Carbohydrate Beverage in people with Anomalies Gastrointestinal, run by Old Dominion University at 1 site in United States.
Trial summary
Several previous studies have shown that repeatedly ingesting carbohydrate supplements during exercise training sessions, over a period of days and weeks, can gradually increase carbohydrate oxidation and reduce gut discomfort during exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anomalies Gastrointestinal
- What is being tested?
- Carbohydrate Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 17 Feb 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be currently running ≥15 miles per week
- Have completed at least one run >60 minutes over the past month
- Have completed one or more marathons within the past year
Who cannot join
- Overt cardiovascular disease or metabolic disorder
- Adverse symptoms (e.g., unusual shortness of breath, dizziness, chest pain) with exercise
- Allergies/intolerances to any of the ingredients in the beverages
Trial locations and contacts
1 site in 1 country.
About this study
Several previous studies have shown that repeatedly ingesting carbohydrate supplements during exercise training sessions, over a period of days and weeks, can gradually increase carbohydrate oxidation and reduce gut discomfort during exercise. However, repeatedly ingesting large amounts of carbohydrate during training sessions can be burdensome and can cause gut distress. Thus, it would be advantageous if the same long-term benefits could be realized from consuming these carbohydrate supplements at rest instead of specifically during training sessions. Therefore, the goal of this study is to examine whether repeatedly ingesting a carbohydrate-rich beverage at rest over a 5-day period alters metabolism and gut symptoms while ingesting carbohydrate during exercise.
- Conditions
- Anomalies Gastrointestinal
- Being tested
- Carbohydrate Beverage, Placebo Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate BeverageDietary supplement
The carbohydrate beverage will supply approximately 100 grams of carbohydrate per day (in the form of glucose and fructose)
Placebo BeverageDietary supplement
The placebo beverage will contain aspartame.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate Beverage | Experimental | A glucose-fructose beverage mixture supplying 100 grams of carbohydrate per day for 5 days Receives: Dietary Supplement: Carbohydrate Beverage |
| Placebo Beverage | Placebo comparator | An artificially-sweetened beverage containing aspartame Receives: Dietary Supplement: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Ratings
Symptoms such as nausea, fullness, belching, reflux, abdominal cramps, flatulence, and urge to defecate will be recorded on a 0-10 scale (0 = no discomfort, 10 = unbearable discomfort).
Measured: Symptoms will be collected during a 60 minute run on a treadmill at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Change in Hydrogen Breath Production
Samples of expired air will be tested for hydrogen levels, a marker of carbohydrate malabsorption
Measured: Samples will be collected before after a 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Secondary outcomes (2)
Change in Carbohydrate Oxidation
Respiratory gases will be used to estimate carbohydrate oxidation rates.
Measured: Respiratory gases will be collected during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Change in Feeling Scale
A bipolar scale ranging from -5 (very bad) to +5 (very good)
Measured: Ratings will be collected collected before and during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Aug 2018
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomalies GastrointestinalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Wilson, PhD, Old Dominion University
- Investigators
- Patrick Wilson, PhD, Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596788
- Sponsor's protocol ID
- 1223706-2
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2018
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running
- ClinicalTrials.gov ID
- NCT03596788
- Acronym / sponsor ID
- 1223706-2
- Conditions
- Anomalies Gastrointestinal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 24 Jul 2018 (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.
Several previous studies have shown that repeatedly ingesting carbohydrate supplements during exercise training sessions, over a period of days and weeks, can gradually increase carbohydrate oxidation and reduce gut discomfort during exercise. However, repeatedly ingesting large amounts of carbohydrate during training sessions can be burdensome and can cause gut distress. Thus, it would be advantageous if the same long-term benefits could be realized from consuming these carbohydrate supplements at rest instead of specifically during training sessions. Therefore, the goal of this study is to examine whether repeatedly ingesting a carbohydrate-rich beverage at rest over a 5-day period alters metabolism and gut symptoms while ingesting carbohydrate during exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate Beverage | Experimental | Dietary Supplement: Carbohydrate BeverageA glucose-fructose beverage mixture supplying 100 grams of carbohydrate per day for 5 days |
| Placebo Beverage | Placebo comparator | Dietary Supplement: Placebo BeverageAn artificially-sweetened beverage containing aspartame |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be currently running ≥15 miles per week
- Have completed at least one run >60 minutes over the past month
- Have completed one or more marathons within the past year
Key exclusion criteria (3 listed)
- Overt cardiovascular disease or metabolic disorder
- Adverse symptoms (e.g., unusual shortness of breath, dizziness, chest pain) with exercise
- Allergies/intolerances to any of the ingredients in the beverages
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 |
|---|---|---|
| Carbohydrate BeverageThe carbohydrate beverage will supply approximately 100 grams of carbohydrate per day (in the form of glucose and fructose) | Dietary supplement | Carbohydrate Beverage |
| Placebo BeverageThe placebo beverage will contain aspartame. | Dietary supplement | Placebo Beverage |
Primary outcome
Change in Gastrointestinal Symptom Ratings
Time frame: Symptoms will be collected during a 60 minute run on a treadmill at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Symptoms such as nausea, fullness, belching, reflux, abdominal cramps, flatulence, and urge to defecate will be recorded on a 0-10 scale (0 = no discomfort, 10 = unbearable discomfort).
Change in Hydrogen Breath Production
Time frame: Samples will be collected before after a 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Samples of expired air will be tested for hydrogen levels, a marker of carbohydrate malabsorption
2 secondary outcomes
Change in Carbohydrate Oxidation
Time frame: Respiratory gases will be collected during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Change in Feeling Scale
Time frame: Ratings will be collected collected before and during each 60-minute run at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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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.
Patrick Wilson, PhD principal investigator
Old Dominion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Beverage in people with Anomalies Gastrointestinal, run by Old Dominion 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Mar 2025. 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 was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
Change in Gastrointestinal Symptom Ratings (time frame: Symptoms will be collected during a 60 minute run on a treadmill at a baseline visit and at a second visit after ingesting the carbohydrate or placebo beverage for 5 days.). The study lists 2 primary outcomes in all. 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 20 Mar 2025.