Protein and Exercise-Induced Gastrointestinal Symptoms
Primary Purpose
Gastro-Intestinal Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Whey protein
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-Intestinal Disorder focused on measuring Dietary protein, Runners, Gastrointestinal symptoms
Eligibility Criteria
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
Sites / Locations
- Mount Royal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low Protein
High Protein
Arm Description
Protein intake at 0.15g/kg body weight
Protein intake at 0.4 g/kg body weight
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Perceive exertion
Perceived exertion during the 10 km challenge run will be measured via Borg Rating of Perceived Exertion scale post run.
Full Information
NCT ID
NCT05855174
First Posted
March 22, 2023
Last Updated
October 18, 2023
Sponsor
Mount Royal University
1. Study Identification
Unique Protocol Identification Number
NCT05855174
Brief Title
Protein and Exercise-Induced Gastrointestinal Symptoms
Official Title
Protein and Exercise-Induced Gastrointestinal Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Royal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Disorder
Keywords
Dietary protein, Runners, Gastrointestinal symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover intervention; all participants will have a low protein and a high protein session.
Masking
Participant
Masking Description
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).
Allocation
Randomized
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Protein
Arm Type
Active Comparator
Arm Description
Protein intake at 0.15g/kg body weight
Arm Title
High Protein
Arm Type
Experimental
Arm Description
Protein intake at 0.4 g/kg body weight
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
Weight protein provided in a shake with carbohydrate and water
Primary Outcome Measure Information:
Title
Self-report exercise induced gastrointestinal symptoms
Description
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.
Time Frame
3 hours per session
Title
Gut fullness
Description
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.
Time Frame
3 hours per session
Secondary Outcome Measure Information:
Title
Plasma glucose levels
Description
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.
Time Frame
3 hours per session
Title
Perceive exertion
Description
Perceived exertion during the 10 km challenge run will be measured via Borg Rating of Perceived Exertion scale post run.
Time Frame
1 hour per session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill A Parnell, PhD
Phone
4034408672
Email
jparnell@mtroyal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn F Madden, PhD
Phone
4033633080
Email
rmadden@mtroyal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill A Parnell, PhD
Organizational Affiliation
Mount Royal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Royal University
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 6K6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill A Parnell, PhD
Phone
4034408672
Email
jparnell@mtroyal.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28323574
Citation
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.
Results Reference
background
PubMed Identifier
28589631
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.
Results Reference
background
PubMed Identifier
28919842
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.
Results Reference
background
PubMed Identifier
32522222
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.
Results Reference
background
PubMed Identifier
21775906
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.
Results Reference
background
PubMed Identifier
26920240
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.
Results Reference
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Protein and Exercise-Induced Gastrointestinal Symptoms
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