Protein Ingestion on BMM Response in Endurance Runners

NCT ID: NCT06645119

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-09-01

Brief Summary

The goal of this clinical trial is to investigate the effects of protein ingestion post-exercise on bone turnover markers. The main questions it aims to answer is:

Does protein ingestion independently influence the bone metabolic response to exercise in endurance runners?

We will compare dietary protein to a placebo (water) to detect changes in bone turnover markers.

Participants will:

In a within-subject design, participants will perform an exhaustive run and take either protein or placebo immediately post-exercise.

Track physical activity and diet before each arm of the intervention and during the washout period.

Detailed Description

Endurance athletes are at increased risk for bone loss and injury due to high-volume training, muscle weakness, and elevated nutritional demand. Dietary practices influence short- and long-term bone health and nutrition supplementation post-exercise may improve the short-term response of bone to exercise and benefit musculoskeletal recovery. However, we have a limited understanding of which dietary practices are most beneficial to optimize bone health in athletic populations. Protein supplementation has long been recommended for muscle adaptation and athletic performance but its potential for bone health has not been thoroughly investigated in endurance athletes. The purpose of this study is to is to investigate the acute independent effects of dietary protein ingestion on bone metabolism in healthy adults aged 18-35 years participating in high-volume endurance running.

Conditions

Dietary Proteins; Acute Exercise; Bone Diseases, Metabolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Whey Protein Beverage

Chocolate flavoured whey protein supplement as a post-exercise recovery beverage. One beverage post-exercise. Dose based on participant body weight.

Group Type: EXPERIMENTAL

Whey Protein Supplement

Intervention Type: DIETARY_SUPPLEMENT

Examining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers.

Control Beverage

Water beverage with calorie-free chocolate syrup as a post-exercise recovery beverage. Isovolumetric.

Group Type: SHAM_COMPARATOR

Whey Protein Supplement

Intervention Type: DIETARY_SUPPLEMENT

Examining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers.

Interventions

Whey Protein Supplement

Examining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 18-35 years of age
• Healthy-range body mass index (BMI) (18.5-24.9 kg/m2)
• Competitive runner for at least one season (minimum 40 km/week for the past 6-months)
• Can read, speak, and understand French and/or English

Exclusion Criteria

• Disease or medication known to affect bone metabolism
• Disease (e.g., uncontrolled thyroid disease, malabsorptive or inflammatory disorder, metabolic bone disease)
• Medication (e.g., hormonal contraceptives the past 3 months, glucocorticoids, anti-hypertensive drugs, anti-epileptic drugs, osteoporosis therapy)
• Orthopedic or musculoskeletal injury/disease that limits the capacity to exercise
• Current smoker or tobacco user
• Current diagnosis of an eating disorder
• Female participants with self-reported or diagnosed:
• Hypothalamic amenorrhea
• Polycystic ovarian syndrome
• Hyperprolactinemia
• Primary ovarian insufficiency
• Pregnant or breastfeeding
• Donated blood within the past two months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Jenna Gibbs

Dr. Jenna Gibbs, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenna Gibbs, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

McGillU

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

PRO-ENDO BONE

Identifier Type: -

Identifier Source: org_study_id