Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

NCT ID: NCT06041087

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-09-01

Brief Summary

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This study investigates whether dairy products will positively impact loading exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory response in healthy young adults compared to a carbohydrate drink and/or water.

Detailed Description

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Introduction: Two million individuals at a cost of around 4.6 billion dollars a year in Canada suffer from osteoporosis. It is important to investigate strategies that can reduce bone loss and/or increase bone mass. Similarly, inflammation is associated with many different disease states, and investigating strategies to reduce systemic inflammation is prudent. Nutrition and exercise may be inexpensive and accessible strategies to improve bone health and inflammation and should be explored in different contexts and implemented. Our proposed research combines both nutrition and exercise along with the assessment of bone turnover and inflammatory markers in healthy young adults.

Design: Randomized controlled crossover trial

Participants: Healthy, university aged males and females.

Methods: During the study participants will complete 4 different acute exercise and nutritional supplement trials, in random order. The four trials are: 1) exercise+carbohydrate (CHO), 2) exercise+milk (Milk), 3) exercise+Greek yogurt (GY), and 4) exercise+water (W). The whole study will take a maximum of 16 weeks and each supplement trial will be separated by 2-4 weeks.

Outcomes: several markers of bone turnover and bone cell activity as well as markers of inflammation will be measured in the blood, before exercise and at different times post-exercise and post supplement consumption.

Conditions

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Healthy Bone Inflammation

Keywords

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Bone health Females Dairy Exercise Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise and Greek Yogurt (GY)

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 Type EXPERIMENTAL

High-Intensity Exercise

Intervention Type BEHAVIORAL

A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Greek yogurt

Intervention Type DIETARY_SUPPLEMENT

200g consumed immediately after exercise and 1h after exercise.

Exercise and Milk (Milk)

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 Type EXPERIMENTAL

High-Intensity Exercise

Intervention Type BEHAVIORAL

A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Skim Milk

Intervention Type DIETARY_SUPPLEMENT

500ml consumed immediately after exercise and 1h after exercise.

Exercise and Carbohydrate (CHO)

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 Type ACTIVE_COMPARATOR

High-Intensity Exercise

Intervention Type BEHAVIORAL

A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Carbohydrate (Maltodextrin powder mixed with water)

Intervention Type DIETARY_SUPPLEMENT

50g consumed immediately after exercise and 1h after exercise.

Exercise and Water (W)

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.

Group Type PLACEBO_COMPARATOR

High-Intensity Exercise

Intervention Type BEHAVIORAL

A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Water

Intervention Type DIETARY_SUPPLEMENT

500ml consumed immediately after exercise and 1h after exercise.

Interventions

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High-Intensity Exercise

A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Intervention Type BEHAVIORAL

Carbohydrate (Maltodextrin powder mixed with water)

50g consumed immediately after exercise and 1h after exercise.

Intervention Type DIETARY_SUPPLEMENT

Skim Milk

500ml consumed immediately after exercise and 1h after exercise.

Intervention Type DIETARY_SUPPLEMENT

Greek yogurt

200g consumed immediately after exercise and 1h after exercise.

Intervention Type DIETARY_SUPPLEMENT

Water

500ml consumed immediately after exercise and 1h after exercise.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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CHO Milk GY W

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 18-30 years
* Normal BMI (18.5-24.9) kg/m\^2
* Low to moderately physically active (0-2 times/week)
* No allergy to dairy protein or lactose intolerance
* On no medication related to a chronic condition
* On birth control or naturally cycling with a regular menstrual cycle)

Exclusion Criteria

* Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis)
* Any chronic condition, inflammatory, or auto-immune condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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York University

OTHER

Sponsor Role lead

Responsible Party

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Andrea Josse

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea R Josse, PhD

Role: PRINCIPAL_INVESTIGATOR

York University

Locations

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York University

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Andrea R Josse, PhD

Role: CONTACT

Phone: 1-416-736-2100

Email: [email protected]

Emily C Fraschetti, MSc

Role: CONTACT

Email: [email protected]

Facility Contacts

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Andrea R Josse, PhD

Role: primary

Emily C Fraschetti, MSc

Role: backup

Other Identifiers

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2019-045b

Identifier Type: -

Identifier Source: org_study_id