- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03596788
Effects of Different Sports Supplements on Metabolism and Perceptual Responses During Distance Running
March 17, 2025 updated by: Patrick Wilson, PhD, Old Dominion University
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23529
- Human Performance Lab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carbohydrate Beverage
A glucose-fructose beverage mixture supplying 100 grams of carbohydrate per day for 5 days
|
The carbohydrate beverage will supply approximately 100 grams of carbohydrate per day (in the form of glucose and fructose)
|
|
Placebo Comparator: Placebo Beverage
An artificially-sweetened beverage containing aspartame
|
The placebo beverage will contain aspartame.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Respiratory gases will be used to estimate carbohydrate oxidation rates.
|
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.
|
A bipolar scale ranging from -5 (very bad) to +5 (very good)
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrick Wilson, PhD, Old Dominion University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
February 17, 2025
Study Completion (Actual)
February 17, 2025
Study Registration Dates
First Submitted
June 28, 2018
First Submitted That Met QC Criteria
July 12, 2018
First Posted (Actual)
July 24, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 17, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 1223706-2
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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