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Clinical Trials/NCT03615989
NCT03615989TerminatedNot Applicable

Does Milk Augment the Acute Effect of Exercise on Bone Turnover and Inflammation

York University1 site in 1 country13 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
13
Locations
1
Primary Endpoint
Acute Bone Cell Activity

Study Overview

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********

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Those completing the analyses were masked to the treatments.

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Exclusion Criteria

  • Not provided

Arms & Interventions

Exercise and Carbohydrate (CHO)

Placebo Comparator

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.

Intervention: Resistance and Plyometric Exercise (Behavioral)

Exercise and Carbohydrate (CHO)

Placebo Comparator

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.

Intervention: Carbohydrate (Maltodextrin powder mixed with water) (Dietary Supplement)

Exercise and Milk (Milk)

Experimental

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.

Intervention: Resistance and Plyometric Exercise (Behavioral)

Exercise and Milk (Milk)

Experimental

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.

Intervention: Skim Milk (Dietary Supplement)

Outcomes

Primary Outcomes

Acute Bone Cell Activity

Time Frame: 48 hours post exercise

Bone markers (OPG, RANKL, OC) measured in serum/plasma.

Acute Bone Cell Activity

Time Frame: Baseline

Bone markers (OPG, RANKL, OC) measured in serum/plasma.

Acute Bone Cell Activity

Time Frame: 5 minutes post exercise

Bone markers (OPG, RANKL, OC) measured in serum/plasma.

Acute Bone Cell Activity

Time Frame: 1 hour post exercise

Bone markers (OPG, RANKL, OC) measured in serum/plasma.

Acute Bone Cell Activity

Time Frame: 24 hours post exercise

Bone markers (OPG, RANKL, OC) measured in serum/plasma.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Josse

Assistant Professor

York University

Study Sites (1)

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