Protein and Exercise-Induced Gastrointestinal Symptoms

Sponsor

Mount Royal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05855174

Collaborator

(none)

Enrollment

Location

Arms

54.6

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastro-Intestinal Disorder	Dietary Supplement: Whey protein	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Single (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).

Primary Purpose:

Treatment

Official Title:

Protein and Exercise-Induced Gastrointestinal Symptoms

Actual Study Start Date :

Mar 13, 2019

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low Protein Protein intake at 0.15g/kg body weight	Dietary Supplement: Whey protein Weight protein provided in a shake with carbohydrate and water
Experimental: High Protein Protein intake at 0.4 g/kg body weight	Dietary Supplement: Whey protein Weight protein provided in a shake with carbohydrate and water

Arm

Intervention/Treatment

Active Comparator: Low Protein

Protein intake at 0.15g/kg body weight

Dietary Supplement: Whey protein

Weight protein provided in a shake with carbohydrate and water

Experimental: High Protein

Protein intake at 0.4 g/kg body weight

Dietary Supplement: Whey protein

Weight protein provided in a shake with carbohydrate and water

Outcome Measures

Primary Outcome Measures

Self-report exercise induced gastrointestinal symptoms [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.
Gut fullness [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.

Secondary Outcome Measures

Plasma glucose levels [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.
Perceive exertion [1 hour per session]
Perceived exertion during the 10 km challenge run will be measured via Borg Rating of Perceived Exertion scale post run.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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