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Carbohydrate Supplements for Gastrointestinal Function During Running

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
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

Study 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.


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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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 • NCT02552355
Diarrhea/Nausea/Stomach Cramps
Eye Infection/Pressure
Leg Cramps/Muscle Soreness
Common Cold
Hair Loss
Study treatment Arm
Metformin: Carbohydrate
Placebo: Carbohydrate
Metformin: 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
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbohydrate Beverage
Completed Phase 2

Find a Location

Who is running the clinical trial?

Old Dominion UniversityLead Sponsor
20 Previous Clinical Trials
15,004 Total Patients Enrolled
Patrick Wilson, PhDPrincipal Investigator - Old Dominion University
Old Dominion University
2 Previous Clinical Trials
85 Total Patients Enrolled

Media Library

Carbohydrate Beverage Clinical Trial Eligibility Overview. Trial Name: NCT03596788 — N/A
Gastrointestinal Anomalies Research Study Groups: Placebo Beverage, Carbohydrate Beverage
Gastrointestinal Anomalies Clinical Trial 2023: Carbohydrate Beverage Highlights & Side Effects. Trial Name: NCT03596788 — N/A
Carbohydrate Beverage 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596788 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are fresh participants permitted to join this trial?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this investigation is currently recruiting participants. Initially posted on August 1st 2018, approximately 40 people are needed to take part in the study from a single site."

Answered by AI

How many test subjects are actively participating in this research?

"Indeed, the clinicaltrials.gov database indicates that this trial is still recruiting patients. It was posted on August 1st 2018 and updated most recently on September 19th 2022. 40 participants are needed to take part in the study at a single medical centre."

Answered by AI
~4 spots leftby Dec 2024