NCT05855174

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

March 22, 2023

Last Update Submit

March 20, 2024

Conditions

Keywords

Dietary proteinRunnersGastrointestinal symptoms

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 COMPARATOR

Protein intake at 0.15g/kg body weight

Dietary Supplement: Whey protein

High Protein

EXPERIMENTAL

Protein intake at 0.4 g/kg body weight

Dietary Supplement: Whey protein

Interventions

Whey proteinDIETARY_SUPPLEMENT

Weight protein provided in a shake with carbohydrate and water

High ProteinLow Protein

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 28323574BACKGROUND
  • 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.

    PMID: 28589631BACKGROUND
  • 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.

    PMID: 28919842BACKGROUND
  • 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.

    PMID: 32522222BACKGROUND
  • 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.

    PMID: 21775906BACKGROUND
  • 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.

    PMID: 26920240BACKGROUND

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jill A Parnell, PhD

    Mount Royal University

    PRINCIPAL INVESTIGATOR

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
Model Details: Crossover intervention; all participants will have a low protein and a high protein session.
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

Locations