Whey Protein for Metabolic Bone Health

(BonePRO Trial)

Not currently recruiting at 1 trial location

Overseen By Silar Gardy, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Must not be taking: Hormonal contraceptives, Glucocorticoids, others

Disqualifiers: Thyroid disease, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how drinking a whey protein shake after exercise might affect bone health in runners. By comparing the effects of protein to drinking only water, researchers aim to determine if protein aids in bone recovery or strengthening after a workout. It suits competitive runners who have logged at least 40 km a week for the past six months. Participants will run intensely, then consume either a protein shake or a calorie-free flavored water to observe their bones' response. As an unphased trial, this study provides runners the opportunity to contribute to understanding how nutrition impacts bone health.

Will I have to stop taking my current medications?

If you are taking medications that affect bone metabolism, such as hormonal contraceptives, glucocorticoids, anti-hypertensive drugs, anti-epileptic drugs, or osteoporosis therapy, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that whey protein supplementation is safe for humans?

Research has shown that whey protein supplements are generally safe for use. For instance, studies have found that taking whey protein for 12 weeks did not significantly affect bone health markers in people with belly fat, suggesting it is well-tolerated. Another study showed that whey protein did not change bone mass in overweight and obese adults over 36 weeks, supporting its safe use for a longer duration.

There are also positive signs for bone health. Whey protein might help increase bone strength and density. Overall, whey protein appears safe based on current research, though further studies would help confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whey protein as a treatment for metabolic bone health because it's a natural protein supplement that could potentially enhance bone strength and recovery. Unlike traditional treatments that often involve medications or supplements like calcium and vitamin D, whey protein offers a post-exercise recovery option that is easy to consume and tailored to individual body weight. Its chocolate-flavored form makes it more appealing for regular use, which might improve adherence to the regimen. By utilizing a natural, dietary approach, this treatment could provide a more holistic and enjoyable way to support bone health.

What evidence suggests that whey protein might be an effective treatment for metabolic bone health?

This trial will compare the effects of a Whey Protein Beverage with a Control Beverage on metabolic bone health. Research has suggested that whey protein might influence bone health, but findings remain mixed. Some studies indicate that increased protein intake can help maintain muscle mass, though strong evidence linking it directly to bone strengthening is lacking. While some research on protein and bone health shows no major changes in bone health markers, other studies hint at possible benefits in specific situations. Overall, the connection between whey protein and bone health continues to be studied, and further research is needed to clarify its exact effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Jenna Gibbs, PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for endurance runners who are interested in how protein affects their bone health after exercise. Participants should be healthy, with no metabolic bone diseases or conditions affecting metabolism. They must track their diet and activity, and not take other supplements that could influence the results.

Inclusion Criteria

Competitive runner for at least one season (minimum 40 km/week for the past 6-months)

My BMI is within the healthy range of 18.5 to 24.9.

I can read, speak, and understand French or English.

Exclusion Criteria

I have been diagnosed with an eating disorder.

My condition or medication affects my bone health.

I do not have uncontrolled thyroid, digestive, or bone diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform an exhaustive run and consume either a whey protein beverage or a placebo immediately post-exercise

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in bone turnover markers up to 24 hours post-exercise

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Whey Protein Supplement

Trial Overview The study tests if drinking whey protein right after running changes markers in the blood that show bone turnover compared to just drinking water. Runners will do an exhaustive run twice: once they'll have protein afterwards, and another time they'll have a placebo.

How Is the Trial Designed?

Group I: Whey Protein Beverage Experimental Treatment 1 Intervention

Chocolate flavoured whey protein supplement as a post-exercise recovery beverage. One beverage post-exercise. Dose based on participant body weight.

Group II: Control Beverage Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4454800/

The Effect of a Whey Protein Supplement on Bone Mass in ... Our data suggest that protein supplementation above the recommended dietary allowance (0.8 g/kg) may preserve fat-free mass without adversely affecting skeletal ...

2. nature.com nature.com/articles/s41598-025-93642-w

Association between dietary protein intake and bone ... This study examines the relationship between dietary protein intake and bone mineral density (BMD) using data from the 2011–2018 National Health and Nutrition ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622106589

Whey Protein Supplementation and Higher Total ... Whey Protein Supplementation and Higher Total Protein Intake Do Not Influence Bone Quantity in Overweight and Obese Adults Following a 36-Week Exercise and ...

4. mdpi.com mdpi.com/2227-9032/12/2/246

Investigating the Health Implications of Whey Protein ... Studies investigating the impact of WP on bone metabolism have produced diverse results. In a pre-clinical study, Amanzadeh et al. [38] found ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9001834/

The Effects of 12-Weeks Whey Protein Supplements on ... Twelve weeks of increased whey protein intake in subjects with abdominal obesity did not affect markers of bone turnover significantly, although tended to ...

6. mdpi.com mdpi.com/2072-6643/15/21/4581

Impact of Dietary Protein on Osteoporosis Development Protein supplementation affects bone mineral density measured by densitometry and metabolic parameters of bone quality, such as bone formation ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10815430/

Investigating the Health Implications of Whey Protein ... Positive impact on bone health, potentially aiding in bone density and strength. Promising role in bone metabolism, further research warranted.

8. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)04927-9/fulltext

Dietary protein and bone health: a systematic review and meta ... Milk basic protein increases bone mineral density and improves bone metabolism ... The effect of a whey protein supplement on bone mass in older Caucasian adults.