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Carbohydrate Supplements for Gastrointestinal Function During Running
N/A
Recruiting
Led By Patrick Wilson, PhD
Research Sponsored by Old Dominion University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Adverse symptoms (e.g., unusual shortness of breath, dizziness, chest pain) with exercise
Overt cardiovascular disease or metabolic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Summary
This trial looks at whether consuming a carbohydrate-rich beverage at rest over a 5-day period alters metabolism and gut symptoms while ingesting carbohydrate during exercise, in order to see if the same long-term benefits could be achieved without specifically consuming the beverage during training sessions.
Who is the study for?
This trial is for distance runners who've done a run over 60 minutes in the past month, are running at least 15 miles weekly, and have finished a marathon in the last year. It's not for those with allergies to beverage ingredients, cardiovascular or metabolic disorders, or who experience symptoms like shortness of breath or chest pain with exercise.Check my eligibility
What is being tested?
The study tests if drinking a carbohydrate-rich beverage while resting (not during training) over five days can change metabolism and reduce gut issues when carbs are consumed during exercise. Participants will compare effects of this drink against a placebo.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort such as bloating, gas, cramps or diarrhea due to high carbohydrate content in the tested beverages.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience symptoms like shortness of breath, dizziness, or chest pain with exercise.
Select...
I have a heart condition or a metabolic disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gastrointestinal Symptom Ratings
Change in Hydrogen Breath Production
Secondary outcome measures
Change in Carbohydrate Oxidation
Change in Feeling Scale
Side effects data
From 2017 Phase 2 trial • 56 Patients • NCT0255235536%
Diarrhea/Nausea/Stomach Cramps
14%
Eye Infection/Pressure
7%
Leg Cramps/Muscle Soreness
7%
Common Cold
7%
Hair Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin: Carbohydrate
Placebo: Carbohydrate
Metformin: Protein
Placebo:Protein
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Carbohydrate BeverageExperimental Treatment1 Intervention
A glucose-fructose beverage mixture supplying 100 grams of carbohydrate per day for 5 days
Group II: Placebo BeveragePlacebo Group1 Intervention
An artificially-sweetened beverage containing aspartame
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbohydrate Beverage
2015
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Old Dominion UniversityLead Sponsor
21 Previous Clinical Trials
15,034 Total Patients Enrolled
Patrick Wilson, PhDPrincipal Investigator - Old Dominion University
Old Dominion University
2 Previous Clinical Trials
85 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience symptoms like shortness of breath, dizziness, or chest pain with exercise.I have a heart condition or a metabolic disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Beverage
- Group 2: Carbohydrate Beverage
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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