The Combined Effect of Dairy and Exercise on Bone and Inflammation

NCT ID: NCT03615989

Last Updated: 2021-05-18

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

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-03-14

Brief Summary

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This study analyzes whether dairy supplementation positively impacts loading exercise-induced bone cell activity and inflammation in healthy young females.

Detailed Description

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Introduction: Two million individuals at a cost of around 2.3 billion dollars a year in Canada suffer from osteoporosis. Research that emphasizes the treatment of this disease is important, but so is research that focuses on prevention; reducing bone loss and/or increasing bone mass when young. In addition, inflammation is an issue as it strongly relates to chronic disease. Countermeasures to improve bone health and inflammation, such as nutrition and exercise, should be explored and implemented. The proposed research combines both nutrition and exercise along with the assessment of bone turnover markers and inflammation in healthy young females, and aims to determine whether dairy versus a carbohydrate-based beverage positively impacts acute bone turnover and the inflammatory response following a bout of resistance and plyometric exercise.

Design: Randomized controlled crossover trial.

Participants: 13 healthy university aged females.

Methods: Participants were asked to complete 2 different acute exercise and nutritional supplement trials. Each trial will be assigned in random order. The two trials were: 1) exercise+carbohydrate (CHO), and 2) exercise+milk (Milk). The whole study, per participant, took a maximum of 8-12 weeks to complete as each supplement trial was separated by \~4 weeks. Each treatment is outlined below.

\*\*\*\*\*\*DUE TO COVID-19, we removed the treatment trial which involved milk+creatine supplementation. Despite randomization, and before the trial was closed, only 11 participants completed this trial\*\*\*\*\*\*\*\*

Anticipated Results: The investigators anticipate that dairy and exercise will have a greater positive impact on acute bone cell activity and inflammation in healthy young females compared to exercise and CHO.

Conditions

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Healthy Females Bone Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized acute Crossover Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Those completing the analyses were masked to the treatments.

Study Groups

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Exercise and Carbohydrate (CHO)

Participants had a fasted, baseline blood sample (10ml) taken upon arrival to the lab. They then completed a supervised resistance and plyometric exercise bout. Immediately following exercise, 50g of carbohydrate (maltodextrin) + water was consumed. Two more blood samples followed the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 50g of carbohydrate was consumed with water 1 hour post exercise. Two more fasting blood samples (10ml) were taken 24 and 48 hours later.

Group Type PLACEBO_COMPARATOR

Resistance and Plyometric Exercise

Intervention Type BEHAVIORAL

A single resistance and plyometric exercise bout per trial.

Carbohydrate (Maltodextrin powder mixed with water)

Intervention Type DIETARY_SUPPLEMENT

50 grams immediately after exercise bout. 50 grams 1 hour after exercise bout.

Exercise and Milk (Milk)

Participants had a fasted, baseline blood sample (10ml) taken upon arrival to the lab. They then completed a supervised resistance and plyometric exercise bout. Immediately following exercise, \~500 ml of skim milk was consumed. Two more blood samples followed the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 500 ml of skim milk was consumed 1 hour post exercise. Two more fasting blood samples (10ml) were taken 24 and 48 hours later.

Group Type EXPERIMENTAL

Resistance and Plyometric Exercise

Intervention Type BEHAVIORAL

A single resistance and plyometric exercise bout per trial.

Skim Milk

Intervention Type DIETARY_SUPPLEMENT

500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.

Interventions

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Resistance and Plyometric Exercise

A single resistance and plyometric exercise bout per trial.

Intervention Type BEHAVIORAL

Carbohydrate (Maltodextrin powder mixed with water)

50 grams immediately after exercise bout. 50 grams 1 hour after exercise bout.

Intervention Type DIETARY_SUPPLEMENT

Skim Milk

500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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CHO Milk

Eligibility Criteria

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Inclusion Criteria

* Female between the ages of 18 and 30 years
* Normal BMI (18.5-24.9) kg/m2
* 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 not but with regular mensural cycle)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brock University

OTHER

Sponsor Role collaborator

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

Countries

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Canada

Other Identifiers

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REB 17-402

Identifier Type: OTHER

Identifier Source: secondary_id

2019-045

Identifier Type: -

Identifier Source: org_study_id

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