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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

BIONEX Trial 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.

BIONEX Trial 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.

BIONEX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-exercise

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

BIONEX 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

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

York UniversityLead Sponsor

58 Previous Clinical Trials

17,451 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the demographic for this clinical trial restricted to a specific age range?

"This clinical trial limits enrolment to individuals between 18 and 30 years old, as per the eligibility criteria."

Answered by AI

Are there any qualifications needed to partake in this trial?

"This trial is accepting 25 individuals between 18 and 30 years old with inflammation. To qualify, participants must not possess any anaphylactic response to dairy proteins or lactose intolerance."

Answered by AI

Does this clinical experiment still have vacancies for test subjects?

"Contrary to the information on clinicaltrials.gov, this particular study is no longer actively recruiting patients after its most recent update of September 13th 2023. But with 1193 other medical trials in operation at present, there are plenty of opportunities for participation elsewhere."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

Andrea Josse 2023. "Bone and Inflammatory Outcomes - Nutrition and Exercise Trials". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041087.

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