Dietary ProteinsBonePRONCT06645119
Protein Ingestion on BMM Response in Endurance Runners
A study testing Whey Protein Supplement in people with Dietary Proteins and Acute Exercise, run by McGill University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Proteins, Acute Exercise, Bone Diseases, Metabolic
- What is being tested?
- Whey Protein Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Whey Protein Supplement
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein SupplementDietary supplement
Examining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Whey Protein Supplement |
| Control Beverage | Sham comparator | Water beverage with calorie-free chocolate syrup as a post-exercise recovery beverage. Isovolumetric. Receives: Dietary Supplement: Whey Protein Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-C-terminal telopeptide
Bone resorption marker
Measured: Up to 24 hours
Procollagen 1 Intact N-Terminal Propeptide
Bone formation marker
Measured: Up to 24 hours
Secondary outcomes (5)
Insulin-like growth factor 1
Hormone involved in bone metabolism
Measured: Up to 24 hours
Sclerostin
Bone turnover maker related to inflammatory response
Measured: Up to 24 hours
OPG
Marker related to bone metabolic response
Measured: Up to 24 hours
RANK/RANKL
Markers related to bone metabolic response
Measured: Up to 24 hours
IL-6
Marker related to bone metabolic response
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Mar 2024
- Primary completion24 Jan 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ProteinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Gibbs, McGill University
- Investigators
- Jenna Gibbs, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645119
- Sponsor's protocol ID
- PRO-ENDO BONE
- Acronym
- BonePRO
- Status last verified
- May 2025
- First submitted
- 30 Nov 2023
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira S, Gardy S, Linardatos J, Churchward-Venne T, Josse A, Correa J, Gibbs J. Acute effects of dietary whey protein supplementation after endurance exercise on serum osteokine and inflammatory cytokine concentrations in endurance runners. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-15. doi: 10.1139/apnm-2025-0346.
PubMed 41506728
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Protein Ingestion on Bone Turnover Biomarkers in Endurance Runners
- ClinicalTrials.gov ID
- NCT06645119
- Acronym / sponsor ID
- BonePRO / PRO-ENDO BONE
- Conditions
- Dietary Proteins, Acute Exercise, Bone Diseases, Metabolic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein Beverage | Experimental | Dietary Supplement: Whey Protein SupplementChocolate flavoured whey protein supplement as a post-exercise recovery beverage. One beverage post-exercise. Dose based on participant body weight. |
| Control Beverage | Sham comparator | Dietary Supplement: Whey Protein SupplementWater beverage with calorie-free chocolate syrup as a post-exercise recovery beverage. Isovolumetric. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein SupplementExamining the independent effect of post-exercise dietary protein ingestion on bone metabolic markers. | Dietary supplement | Control Beverage, Whey Protein Beverage |
Primary outcome
Beta-C-terminal telopeptide
Time frame: Up to 24 hours
Bone resorption marker
Procollagen 1 Intact N-Terminal Propeptide
Time frame: Up to 24 hours
Bone formation marker
5 secondary outcomes
Insulin-like growth factor 1
Time frame: Up to 24 hours
Sclerostin
Time frame: Up to 24 hours
OPG
Time frame: Up to 24 hours
RANK/RANKL
Time frame: Up to 24 hours
IL-6
Time frame: Up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Derived from this study: PubMed 41506728Ferreira S, Gardy S, Linardatos J, Churchward-Venne T, Josse A, Correa J, Gibbs J. Acute effects of dietary whey protein supplementation after endurance exercise on serum osteokine and inflammatory cytokine concentrations in endurance runners. Appl Physiol Nutr Metab. 2026 Jan 1;51:1-15. doi: 10.1139/apnm-2025-0346.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna Gibbs, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Supplement in people with Dietary Proteins and Acute Exercise, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-C-terminal telopeptide (time frame: Up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06645119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.