Protein Ingestion on BMM Response in Endurance Runners

NCT06645119 | Active Not Recruiting

• 1 other identifier: PRO-ENDO BONE
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Proteins; Acute Exercise; Bone Diseases, Metabolic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Insulin-like growth factor 1

  Up to 24 hours

• Sclerostin

  Up to 24 hours

• OPG

  Up to 24 hours

• RANK/RANKL

  Up to 24 hours

• IL-6

  Up to 24 hours

Study Arms (2)

Whey Protein Beverage

EXPERIMENTAL

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

Control Beverage

SHAM COMPARATOR

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

Dietary Supplement: Whey Protein Supplement

Interventions

Whey Protein Supplement DIETARY_SUPPLEMENT

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

Control Beverage; Whey Protein Beverage

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGillU

Montreal, Quebec, H3A 0G4, Canada

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jenna Gibbs, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jenna Gibbs, Assistant Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: October 16, 2024
• Study Start: March 1, 2024
• Primary Completion: January 24, 2025
• Study Completion: September 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)