The Combined Effect of Dairy and Exercise on Bone and Inflammation

Healthy Clinical Trial

— Cre-Ex-Inf  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03615989
• Other study ID #: 2019-045
• Secondary ID: REB 17-402
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 14, 2020

Study information

• Verified date: May 2021
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 14, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone
• Females
• Healthy
• Inflammation

Intervention

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.
• Skim Milk
500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
York University	Brock University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammation	Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	Baseline
Other	Inflammation	Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	5 minutes post exercise
Other	Inflammation	Interleukin 6, Interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	1 hour post exercise
Other	Inflammation	Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	24 hour post exercise
Other	Inflammation	Interleukin 6, interleukin 10, Interleukin 1B, TNFa measured in serum/plasma.	48 hour post exercise
Primary	Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	Baseline
Primary	Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	Baseline
Primary	Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	Baseline
Primary	Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	5 minutes post exercise
Primary	Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	5 minutes post exercise
Primary	Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	5 minutes post exercise
Primary	Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	1 hour post exercise
Primary	Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	1 hour post exercise
Primary	Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	1 hour post exercise
Primary	Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	24 hours post exercise
Primary	Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	24 hours post exercise
Primary	Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	24 hours post exercise
Primary	Acute Bone Cell Activity	Bone markers (OPG, RANKL, OC) measured in serum/plasma.	48 hours post exercise
Primary	Acute Bone Cell Activity	Bone markers (SOST) measured in serum/plasma.	48 hours post exercise
Primary	Acute Bone Cell Activity	Bone markers (CTX) measured in serum/plasma.	48 hours post exercise