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

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

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

Study Overview

• Status: Terminated
• Conditions: Inflammation; Healthy; Bone; Females
• Intervention / Treatment: Behavioral: Resistance and Plyometric Exercise; Dietary supplement: Carbohydrate (Maltodextrin powder mixed with water); Dietary supplement: Skim Milk

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3J 1P3
      • York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: Resistance and Plyometric Exercise; A single resistance and plyometric exercise bout per trial.; Dietary supplement: Carbohydrate (Maltodextrin powder mixed with water); 50 grams immediately after exercise bout. 50 grams 1 hour after exercise bout.; Other Names: CHO
Experimental: 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.	Behavioral: Resistance and Plyometric Exercise; A single resistance and plyometric exercise bout per trial.; Dietary supplement: Skim Milk; 500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.; Other Names: Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	Baseline
Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	Baseline
Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	Baseline
Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	5 minutes post exercise
Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	5 minutes post exercise
Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	5 minutes post exercise
Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	1 hour post exercise
Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	1 hour post exercise
Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	1 hour post exercise
Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	24 hours post exercise
Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	24 hours post exercise
Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	24 hours post exercise
Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	48 hours post exercise
Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	48 hours post exercise
Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	48 hours post exercise

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	Baseline
Inflammation	Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	5 minutes post exercise
Inflammation	Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	1 hour post exercise
Inflammation	Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	24 hour post exercise
Inflammation	Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	48 hour post exercise

Collaborators and Investigators

• Sponsor: York University
• Collaborators: Brock University
• Investigators: Principal Investigator: Andrea R Josse, PhD, York University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 14, 2020
• Study Completion (Actual): March 14, 2020

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Exercise; Dairy; Bone Health; Females
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2019-045; REB 17-402 (Other Identifier: Brock University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No