Protein and Exercise-Induced Gastrointestinal Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2023-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Protein-Prebiotic Wellbeing Study

NCT05303753

Digestive Health Quality of Life

COMPLETED NA

The Effect of Increasing Dietary Protein on the Gut Microbiome and Its Metabolites

NCT06677333

Health Adults

COMPLETED NA

The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females

NCT03571425

Healthy

COMPLETED NA

Protein Intake and Physical Performance

NCT02594228

Physical Performance

COMPLETED NA

Effects of Protein Ingestion and Exercise Training on Muscular Performance

NCT02593656

Physical Performance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastro-Intestinal Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Protein

Protein intake at 0.15g/kg body weight

Group Type ACTIVE_COMPARATOR

Whey protein

Intervention Type DIETARY_SUPPLEMENT

Weight protein provided in a shake with carbohydrate and water

High Protein

Protein intake at 0.4 g/kg body weight

Group Type EXPERIMENTAL

Whey protein

Intervention Type DIETARY_SUPPLEMENT

Weight protein provided in a shake with carbohydrate and water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey protein

Weight protein provided in a shake with carbohydrate and water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes