Active — Not RecruitingNot Applicable

Protein Ingestion on BMM Response in Endurance Runners

Canada14 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Beta-C-terminal telopeptide

Timeframe: Up to 24 hours

Procollagen 1 Intact N-Terminal Propeptide

Timeframe: Up to 24 hours

Trial details

NCT IDNCT06645119

SponsorMcGill University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-24

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