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NCT Number: NCT06645119

Protein Ingestion on BMM Response 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGillU

Montreal, Quebec, H3A 0G4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein Supplement

Dietary Supplement

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

Primary outcomes

  1. Beta-C-terminal telopeptide

    Time frame: Up to 24 hours

    Bone resorption marker

  2. Procollagen 1 Intact N-Terminal Propeptide

    Time frame: Up to 24 hours

    Bone formation marker

Secondary outcomes

  1. Insulin-like growth factor 1

    Time frame: Up to 24 hours

    Hormone involved in bone metabolism

  2. Sclerostin

    Time frame: Up to 24 hours

    Bone turnover maker related to inflammatory response

  3. OPG

    Time frame: Up to 24 hours

    Marker related to bone metabolic response

  4. RANK/RANKL

    Time frame: Up to 24 hours

    Markers related to bone metabolic response

  5. IL-6

    Time frame: Up to 24 hours

    Marker related to bone metabolic response

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Acronym: BonePRO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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