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Behavioral Intervention

Dairy vs Carbs vs Water for Bone Health and Inflammation (BIONEX Trial)

N/A
Recruiting
Led By Andrea R Josse, PhD
Research Sponsored by York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 18-30 years
On no medication related to a chronic condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post-exercise
Awards & highlights

Summary

This trial tests if dairy can help bones & reduce inflammation after exercise in healthy young adults, compared to carbs or water.

Who is the study for?
This trial is for healthy young adults aged 18-30 with a normal BMI who are low to moderately active. Participants must either be on birth control or have regular menstrual cycles, and not be taking medication for chronic conditions. They should not have allergies to dairy protein, lactose intolerance, or smoke regularly.Check my eligibility
What is being tested?
The study is examining if consuming dairy products like Greek yogurt and skim milk can influence bone health and reduce inflammation after high-intensity exercise compared to just having a carbohydrate drink (maltodextrin powder in water) or plain water.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to dairy consumption, especially in individuals who might discover they are sensitive to lactose despite no known intolerance. High-intensity exercise may also cause muscle soreness.

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 30 years old.
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I am not on any medication for a chronic condition.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Bone Turnover/Cell Activity
Systemic Inflammation - Serum/Plasma Cytokines
Systemic inflammation - Immune Cells
Secondary outcome measures
Muscle soreness
Performance - Jump Height

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Exercise and Milk (Milk)Experimental Treatment2 Interventions
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Group II: Exercise and Greek Yogurt (GY)Experimental Treatment2 Interventions
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Group III: Exercise and Carbohydrate (CHO)Active Control2 Interventions
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~50g of maltodextrin mixed with water (~500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Group IV: Exercise and Water (W)Placebo Group2 Interventions
Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume ~500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional ~500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skim Milk
2018
N/A
~80
Greek yogurt
2011
N/A
~60

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for inflammation include dietary interventions such as the intake of dairy products rich in calcium and protein. Calcium supports bone health by aiding in bone turnover and bone cell activity, while protein provides essential amino acids that help repair tissues and modulate inflammatory responses. These nutrients can reduce the post-exercise inflammatory response, which is particularly beneficial for inflammation patients as it helps in managing symptoms and improving overall health. By incorporating these nutrients, patients may experience reduced inflammation and better bone health, contributing to a higher quality of life.

Find a Location

Who is running the clinical trial?

York UniversityLead Sponsor
62 Previous Clinical Trials
518,452 Total Patients Enrolled
3 Trials studying Inflammation
85 Patients Enrolled for Inflammation
Andrea R Josse, PhDPrincipal InvestigatorYork University
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Inflammation
13 Patients Enrolled for Inflammation
~10 spots leftby Dec 2024