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

Sponsor

York University (Other)

Overall Status

Terminated

CT.gov ID

NCT03615989

Collaborator

Brock University (Other)

Enrollment

Location

Arms

17.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Females Bone Inflammation	Behavioral: Resistance and Plyometric Exercise Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water) Dietary Supplement: Skim Milk	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized acute Crossover TrialRandomized acute Crossover Trial

Masking:

Single (Outcomes Assessor)

Masking Description:

Those completing the analyses were masked to the treatments.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Mar 14, 2020

Actual Study Completion Date :

Mar 14, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Other Outcome Measures

Inflammation [Baseline]
Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Inflammation [5 minutes post exercise]
Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Inflammation [1 hour post exercise]
Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Inflammation [24 hour post exercise]
Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.
Inflammation [48 hour post exercise]
Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	York University	Toronto	Ontario	Canada	M3J 1P3

Sponsors and Collaborators

York University
Brock University

Investigators

Principal Investigator: Andrea R Josse, PhD, York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Josse, Assistant Professor, York University

ClinicalTrials.gov Identifier:

NCT03615989

Other Study ID Numbers:

2019-045
REB 17-402

First Posted:

Aug 6, 2018

Last Update Posted:

May 18, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrea Josse, Assistant Professor, York University

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of May 18, 2021