search
Back to results

The Combined Effect of Dairy and Exercise on Bone and Inflammation (Cre-Ex-Inf)

Primary Purpose

Healthy, Females, Bone

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resistance and Plyometric Exercise
Carbohydrate (Maltodextrin powder mixed with water)
Skim Milk
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Bone Health, Females, Dairy, Exercise, Inflammation

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • York University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Exercise and Carbohydrate (CHO)

Exercise and Milk (Milk)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Acute Bone Cell Activity
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (SOST) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (CTX) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (SOST) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (CTX) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (SOST) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (CTX) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (SOST) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (CTX) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (SOST) measured in serum/plasma.
Acute Bone Cell Activity
Bone markers (CTX) measured in serum/plasma.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2018
Last Updated
May 13, 2021
Sponsor
York University
Collaborators
Brock University
search

1. Study Identification

Unique Protocol Identification Number
NCT03615989
Brief Title
The Combined Effect of Dairy and Exercise on Bone and Inflammation
Acronym
Cre-Ex-Inf
Official Title
Does Milk Augment the Acute Effect of Exercise on Bone Turnover and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 14, 2020 (Actual)
Study Completion Date
March 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Brock University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Females, Bone, Inflammation
Keywords
Bone Health, Females, Dairy, Exercise, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized acute Crossover Trial
Masking
Outcomes Assessor
Masking Description
Those completing the analyses were masked to the treatments.
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Carbohydrate (CHO)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Exercise and Milk (Milk)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Resistance and Plyometric Exercise
Intervention Description
A single resistance and plyometric exercise bout per trial.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate (Maltodextrin powder mixed with water)
Other Intervention Name(s)
CHO
Intervention Description
50 grams immediately after exercise bout. 50 grams 1 hour after exercise bout.
Intervention Type
Dietary Supplement
Intervention Name(s)
Skim Milk
Other Intervention Name(s)
Milk
Intervention Description
500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.
Primary Outcome Measure Information:
Title
Acute Bone Cell Activity
Description
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Time Frame
Baseline
Title
Acute Bone Cell Activity
Description
Bone markers (SOST) measured in serum/plasma.
Time Frame
Baseline
Title
Acute Bone Cell Activity
Description
Bone markers (CTX) measured in serum/plasma.
Time Frame
Baseline
Title
Acute Bone Cell Activity
Description
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Time Frame
5 minutes post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (SOST) measured in serum/plasma.
Time Frame
5 minutes post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (CTX) measured in serum/plasma.
Time Frame
5 minutes post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Time Frame
1 hour post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (SOST) measured in serum/plasma.
Time Frame
1 hour post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (CTX) measured in serum/plasma.
Time Frame
1 hour post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Time Frame
24 hours post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (SOST) measured in serum/plasma.
Time Frame
24 hours post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (CTX) measured in serum/plasma.
Time Frame
24 hours post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (OPG, RANKL, OC) measured in serum/plasma.
Time Frame
48 hours post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (SOST) measured in serum/plasma.
Time Frame
48 hours post exercise
Title
Acute Bone Cell Activity
Description
Bone markers (CTX) measured in serum/plasma.
Time Frame
48 hours post exercise
Other Pre-specified Outcome Measures:
Title
Inflammation
Description
Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Time Frame
Baseline
Title
Inflammation
Description
Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Time Frame
5 minutes post exercise
Title
Inflammation
Description
Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Time Frame
1 hour post exercise
Title
Inflammation
Description
Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Time Frame
24 hour post exercise
Title
Inflammation
Description
Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Time Frame
48 hour post exercise

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea R Josse, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1P3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Combined Effect of Dairy and Exercise on Bone and Inflammation

We'll reach out to this number within 24 hrs