Protein and Exercise-Induced Gastrointestinal Symptoms

Gastro-Intestinal Disorder Clinical Trial

Official title:

Protein and Exercise-Induced Gastrointestinal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855174
• Other study ID #: MountRoyalU
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: December 21, 2023

Study information

• Verified date: March 2024
• Source: Mount Royal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

Dietary Supplement:
• Whey protein
Weight protein provided in a shake with carbohydrate and water

Locations

Country	Name	City	State
Canada	Mount Royal University	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Mount Royal University

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Plasma glucose levels	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
Secondary	Perceive exertion	Perceived exertion during the 10 km challenge run will be measured via Borg Rating of Perceived Exertion scale post run.	1 hour per session