- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855174
Protein and Exercise-Induced Gastrointestinal Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Context: Proper nutrition is crucial for peak sport performance. Recommendations for carbohydrate intakes in the pre-exercise meal for endurance athletes are available; however, are lacking for protein. Furthermore, a recent position statement regarding nutrient timing for exercise also lacks protein recommendations. The only advice provided is to avoid "too much" as it may cause gastrointestinal (GI) discomfort. The aforementioned recommendation provides no guidance as to how much is "too much" nor, to our knowledge, is there any clinical trial data to support the position. Exercise-associated gastrointestinal symptoms are a common cause of withdrawal from competition; thus, athletes need to consider the impact of dietary choices on gastrointestinal (GI) symptoms, as well as performance. Exercise induced GI symptoms can plague all athletes; but the effects seem to be most pronounced in endurance running. The reported prevalence of exercise-induced GI disturbances varies depending on methodology; however a questionnaire administered by the investigator's lab to 440 runners found 41% experienced stomach pain/cramps, 24% had intestinal issues, and over 20% reported bloating, diarrhea and/or gas. Exercise related GI complaints have been broadly related to diet. Research from the investigator's lab has found that many of the top foods that are avoided pre-running, to reduce GI symptoms, are those classified as high in protein (legumes, meat, poultry, fish, milk). These observations are based on self-reported data from experienced runners, and require testing in a clinical setting.
Objectives: 1) to quantify exercise induced gastrointestinal symptoms and gut fullness occurring in response to a low protein (control) and high protein (intervention) pre-exercise meal. 2) to quantify blood glucose responses to a high protein pre-exercise meal as compared to a low protein control.
Methods: The study is a single blind crossover design. Endurance runners will be ask to standardize their exercise 3-days prior to testing. The participants will be asked to eat a similar meal in the 24-12 hours pre-testing and fast for 12 hours pre-testing. The participants will be assigned to consume a pre-exercise shake with carbohydrate at 0.75g/kg body weight + water at 5ml/kg body weight and either low whey protein control or high whey protein intervention one hour pre-exercise in a randomized fashion. Participants will then complete a 10 km running protocol at 85% of the participant's race pace on a treadmill in an temperature and humidity controlled room. Gastrointestinal symptoms via self-report questionnaire and blood glucose will be measured at fasting, during the one hour digestive period and post-exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jill A Parnell, PhD
- Phone Number: 4034408672
- Email: jparnell@mtroyal.ca
Study Contact Backup
- Name: Robyn F Madden, PhD
- Phone Number: 4033633080
- Email: rmadden@mtroyal.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3E 6K6
- Mount Royal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- recreational competitive runners, defined as running at least 25 km per week
- experiences exercise-induced gastrointestinal symptoms while running
Exclusion Criteria:
- individuals with food allergies,
- gastrointestinal disorders (e.g., celiac disease, irritable bowl syndrome, etc.)
- adherence to a special diet
- pregnancy
- pre-existing medical condition that would prevent them from completing the prescribed exercise
- blood-borne illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low Protein
Protein intake at 0.15g/kg body weight
|
Weight protein provided in a shake with carbohydrate and water
|
Experimental: High Protein
Protein intake at 0.4 g/kg body weight
|
Weight protein provided in a shake with carbohydrate and water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-report exercise induced gastrointestinal symptoms
Time Frame: 3 hours per session
|
Quantify exercise induced gastrointestinal symptoms via a 0-9 point Likert scale questionnaire including 6 questions for upper abdominal problems, 7 questions for lower abdominal problems and 5 systemic problems.
Likert scale questions are administered at fasting, pre-exercise and post-exercise.
Questionnaires are administered in response to a low protein (control) and a high protein pre-exercise meal.
|
3 hours per session
|
Gut fullness
Time Frame: 3 hours per session
|
Gut fullness measured using a 100mm visual analogue scale anchored by not full at all and very full at fasting 15, 30 and 60 minutes post-meal and post run.
Questionnaires are administered in response to a low protein (control) and a high protein pre-exercise meal.
|
3 hours per session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma glucose levels
Time Frame: 3 hours per session
|
Quantify blood glucose levels via a finger prick and blood glucose meter in response to a high protein pre-exercise meal as compared to a low protein control at fasting, 30 minutes post meal, 60 minutes post-meal and post 10 km run.
|
3 hours per session
|
Perceive exertion
Time Frame: 1 hour per session
|
Perceived exertion during the 10 km challenge run will be measured via Borg Rating of Perceived Exertion scale post run.
|
1 hour per session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jill A Parnell, PhD, Mount Royal University
Publications and helpful links
General Publications
- Thomas DT, Erdman KA, Burke LM. Position of the Academy of Nutrition and Dietetics, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J Acad Nutr Diet. 2016 Mar;116(3):501-528. doi: 10.1016/j.jand.2015.12.006. Erratum In: J Acad Nutr Diet. 2017 Jan;117(1):146.
- Briggs MA, Harper LD, McNamee G, Cockburn E, Rumbold PLS, Stevenson EJ, Russell M. The effects of an increased calorie breakfast consumed prior to simulated match-play in Academy soccer players. Eur J Sport Sci. 2017 Aug;17(7):858-866. doi: 10.1080/17461391.2017.1301560. Epub 2017 Mar 21.
- Costa RJS, Snipe RMJ, Kitic CM, Gibson PR. Systematic review: exercise-induced gastrointestinal syndrome-implications for health and intestinal disease. Aliment Pharmacol Ther. 2017 Aug;46(3):246-265. doi: 10.1111/apt.14157. Epub 2017 Jun 7.
- Kerksick CM, Arent S, Schoenfeld BJ, Stout JR, Campbell B, Wilborn CD, Taylor L, Kalman D, Smith-Ryan AE, Kreider RB, Willoughby D, Arciero PJ, VanDusseldorp TA, Ormsbee MJ, Wildman R, Greenwood M, Ziegenfuss TN, Aragon AA, Antonio J. International society of sports nutrition position stand: nutrient timing. J Int Soc Sports Nutr. 2017 Aug 29;14:33. doi: 10.1186/s12970-017-0189-4. eCollection 2017.
- Parnell JA, Wagner-Jones K, Madden RF, Erdman KA. Dietary restrictions in endurance runners to mitigate exercise-induced gastrointestinal symptoms. J Int Soc Sports Nutr. 2020 Jun 10;17(1):32. doi: 10.1186/s12970-020-00361-w.
- Pfeiffer B, Stellingwerff T, Hodgson AB, Randell R, Pottgen K, Res P, Jeukendrup AE. Nutritional intake and gastrointestinal problems during competitive endurance events. Med Sci Sports Exerc. 2012 Feb;44(2):344-51. doi: 10.1249/MSS.0b013e31822dc809.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MountRoyalU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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