Protein and Exercise-Induced Gastrointestinal Symptoms
1 other identifier
interventional
13
1 country
1
Brief Summary
Recommendations for carbohydrate intakes in the pre-exercise meal for endurance athletes are available; however, are lacking protein. Therefore, the purpose of this study is to quantify exercise-induced gastrointestinal symptoms and gut fullness occurring in response to a low protein (control) and a high protein (intervention) pre-exercise meal. The secondary purpose is to quantify blood glucose responses to a high-protein pre-exercise meal as compared to a low-protein control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2019
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2023
CompletedMarch 21, 2024
March 1, 2024
4.8 years
March 22, 2023
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Self-report exercise induced gastrointestinal symptoms
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
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 Outcomes (2)
Plasma glucose levels
3 hours per session
Perceive exertion
1 hour per session
Study Arms (2)
Low Protein
ACTIVE COMPARATORProtein intake at 0.15g/kg body weight
High Protein
EXPERIMENTALProtein intake at 0.4 g/kg body weight
Interventions
Weight protein provided in a shake with carbohydrate and water
Eligibility Criteria
You may qualify if:
- recreational competitive runners, defined as running at least 25 km per week
- experiences exercise-induced gastrointestinal symptoms while running
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Royal University
Calgary, Alberta, T3E 6K6, Canada
Related Publications (6)
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.
PMID: 28323574BACKGROUNDCosta 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.
PMID: 28589631BACKGROUNDKerksick 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.
PMID: 28919842BACKGROUNDParnell 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.
PMID: 32522222BACKGROUNDPfeiffer 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.
PMID: 21775906BACKGROUNDThomas 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.
PMID: 26920240BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill A Parnell, PhD
Mount Royal University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- In this single-blinded crossover design, the participants will be blinded to which intervention the participants are receiving (i.e., high protein or low protein drinks).
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2023
First Posted
May 11, 2023
Study Start
March 13, 2019
Primary Completion
December 21, 2023
Study Completion
December 21, 2023
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share