Protein Ingestion on BMM Response in Endurance Runners (BonePRO)

Acute Effects of Protein Ingestion on Bone Turnover Biomarkers in Endurance Runners

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Diseases, Metabolic; Dietary Proteins; Acute Exercise
• Intervention / Treatment: Dietary supplement: Whey Protein Supplement

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3A 0G4
      • McGillU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whey Protein Beverage; Chocolate flavoured whey protein supplement as a post-exercise recovery beverage. One beverage post-exercise. Dose based on participant body weight.	Dietary supplement: Whey Protein Supplement; Examining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers.
Sham Comparator: Control Beverage; Water beverage with calorie-free chocolate syrup as a post-exercise recovery beverage. Isovolumetric.	Dietary supplement: Whey Protein Supplement; Examining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta-C-terminal telopeptide	Bone resorption marker	Up to 24 hours
Procollagen 1 Intact N-Terminal Propeptide	Bone formation marker	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin-like growth factor 1	Hormone involved in bone metabolism	Up to 24 hours
Sclerostin	Bone turnover maker related to inflammatory response	Up to 24 hours
OPG	Marker related to bone metabolic response	Up to 24 hours
RANK/RANKL	Markers related to bone metabolic response	Up to 24 hours
IL-6	Marker related to bone metabolic response	Up to 24 hours

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Jenna Gibbs, PhD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): January 24, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: PRO-ENDO BONE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No