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Protein Supplement

Whey Protein for Metabolic Bone Health (BonePRO Trial)

N/A
Recruiting
Led By Jenna Gibbs, PhD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-35 years of age
Healthy-range body mass index (BMI) (18.5-24.9 kg/m2)
Must not have
Current diagnosis of an eating disorder
Donated blood within the past two months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours

Summary

This trial aims to study the impact of consuming protein after exercise on bone health markers. They want to know if protein intake affects how the body responds to exercise in endurance runners. Participants will be given either

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Whey protein is generally safe but can cause digestive issues like bloating or gas in some people. Since it's being compared to water (placebo), any side effects would likely be mild and related to digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 35 years old.
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My BMI is within the healthy range of 18.5 to 24.9.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an eating disorder.
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I have not donated blood in the last two months.
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I have a bone or muscle condition that stops me from exercising.
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I am a woman with a diagnosed reproductive health condition or am pregnant/breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Beta-C-terminal telopeptide
Procollagen 1 Intact N-Terminal Propeptide
Secondary study objectives
IL-6
Insulin-like growth factor 1
OPG
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Whey Protein BeverageExperimental Treatment1 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 BeveragePlacebo Group1 Intervention
Water beverage with calorie-free chocolate syrup as a post-exercise recovery beverage. Isovolumetric.

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Who is running the clinical trial?

McGill UniversityLead Sponsor
411 Previous Clinical Trials
1,018,482 Total Patients Enrolled
Jenna Gibbs, PhDPrincipal InvestigatorMcGill University
~0 spots leftby Nov 2024
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