Clinical trial NCT03615989: The Combined Effect of Dairy and Exercise on Bone and Inflammation
Official title: Does Milk Augment the Acute Effect of Exercise on Bone Turnover and Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Females
Bone
Inflammation
Keywords: Bone Health
Females
Dairy
Exercise
Inflammation
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Brock University
First posted: 2018-08-06
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized acute Crossover Trial
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acute Bone Cell Activity
timeFrame: Baseline
measure: Acute Bone Cell Activity
timeFrame: Baseline
measure: Acute Bone Cell Activity
timeFrame: Baseline
measure: Acute Bone Cell Activity
timeFrame: 5 minutes post exercise
measure: Acute Bone Cell Activity
timeFrame: 5 minutes post exercise
measure: Acute Bone Cell Activity
timeFrame: 5 minutes post exercise
measure: Acute Bone Cell Activity
timeFrame: 1 hour post exercise
measure: Acute Bone Cell Activity
timeFrame: 1 hour post exercise
measure: Acute Bone Cell Activity
timeFrame: 1 hour post exercise
measure: Acute Bone Cell Activity
timeFrame: 24 hours post exercise
measure: Acute Bone Cell Activity
timeFrame: 24 hours post exercise
measure: Acute Bone Cell Activity
timeFrame: 24 hours post exercise
measure: Acute Bone Cell Activity
timeFrame: 48 hours post exercise
measure: Acute Bone Cell Activity
timeFrame: 48 hours post exercise
measure: Acute Bone Cell Activity
timeFrame: 48 hours post exercise
Secondary outcomes:
Other outcomes:
measure: Inflammation
timeFrame: Baseline
measure: Inflammation
timeFrame: 5 minutes post exercise
measure: Inflammation
timeFrame: 1 hour post exercise
measure: Inflammation
timeFrame: 24 hour post exercise
measure: Inflammation
timeFrame: 48 hour post exercise
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Andrea R Josse, PhD
role: PRINCIPAL_INVESTIGATOR
References: