Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

Healthy Clinical Trial

— BIONEX  

Official title:

Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041087
• Other study ID #: 2019-045b
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2023
• Source: York University
• Contact: Andrea R Josse, PhD
• Phone: 1-416-736-2100
• Email: ajosse[@]yorku.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether dairy products will positively impact loading exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory response in healthy young adults compared to a carbohydrate drink and/or water.

Description:

Introduction: Two million individuals at a cost of around 4.6 billion dollars a year in Canada suffer from osteoporosis. It is important to investigate strategies that can reduce bone loss and/or increase bone mass. Similarly, inflammation is associated with many different disease states, and investigating strategies to reduce systemic inflammation is prudent. Nutrition and exercise may be inexpensive and accessible strategies to improve bone health and inflammation and should be explored in different contexts and implemented. Our proposed research combines both nutrition and exercise along with the assessment of bone turnover and inflammatory markers in healthy young adults.

Design: Randomized controlled crossover trial

Participants: Healthy, university aged males and females.

Methods: During the study participants will complete 4 different acute exercise and nutritional supplement trials, in random order. The four trials are: 1) exercise+carbohydrate (CHO), 2) exercise+milk (Milk), 3) exercise+Greek yogurt (GY), and 4) exercise+water (W). The whole study will take a maximum of 16 weeks and each supplement trial will be separated by 2-4 weeks.

Outcomes: several markers of bone turnover and bone cell activity as well as markers of inflammation will be measured in the blood, before exercise and at different times post-exercise and post supplement consumption.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18-30 years

• Normal BMI (18.5-24.9) kg/m^2

• 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 naturally cycling with a regular menstrual cycle)

Exclusion Criteria:

• Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis)

• Any chronic condition, inflammatory, or auto-immune condition

Related Conditions & MeSH terms

• Bone
• Healthy
• Inflammation

Intervention

Behavioral:
• High-Intensity Exercise
A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Dietary Supplement:
• Carbohydrate (Maltodextrin powder mixed with water)
50g consumed immediately after exercise and 1h after exercise.
• Skim Milk
500ml consumed immediately after exercise and 1h after exercise.
• Greek yogurt
200g consumed immediately after exercise and 1h after exercise.
• Water
500ml consumed immediately after exercise and 1h after exercise.

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Bone Turnover/Cell Activity	OPG measured in serum/plasma	Pre-exercise
Primary	Acute Bone Turnover/Cell Activity	RANKL measured in serum/plasma	Pre-exercise
Primary	Acute Bone Turnover/Cell Activity	OC measured in serum/plasma	Pre-exercise
Primary	Acute Bone Turnover/Cell Activity	SOST measured in serum/plasma	Pre-exercise
Primary	Acute Bone Turnover/Cell Activity	CTX measured in serum/plasma	Pre-exercise
Primary	Acute Bone Turnover/Cell Activity	OPG measured in serum/plasma	5 minutes post-exercise
Primary	Acute Bone Turnover/Cell Activity	RANKL measured in serum/plasma	5 minutes post-exercise
Primary	Acute Bone Turnover/Cell Activity	OC measured in serum/plasma	5 minutes post-exercise
Primary	Acute Bone Turnover/Cell Activity	SOST measured in serum/plasma	5 minutes post-exercise
Primary	Acute Bone Turnover/Cell Activity	CTX measured in serum/plasma	5 minutes post-exercise
Primary	Acute Bone Turnover/Cell Activity	OPG measured in serum/plasma	1 hour post-exercise
Primary	Acute Bone Turnover/Cell Activity	RANKL measured in serum/plasma	1 hour post-exercise
Primary	Acute Bone Turnover/Cell Activity	OC measured in serum/plasma	1 hour post-exercise
Primary	Acute Bone Turnover/Cell Activity	SOST measured in serum/plasma	1 hour post-exercise
Primary	Acute Bone Turnover/Cell Activity	CTX measured in serum/plasma	1 hour post-exercise
Primary	Acute Bone Turnover/Cell Activity	OPG measured in serum/plasma	4 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	RANKL measured in serum/plasma	4 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	OC measured in serum/plasma	4 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	SOST measured in serum/plasma	4 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	CTX measured in serum/plasma	4 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	OPG measured in serum/plasma	24 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	RANKL measured in serum/plasma	24 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	OC measured in serum/plasma	24 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	SOST measured in serum/plasma	24 hours post-exercise
Primary	Acute Bone Turnover/Cell Activity	CTX measured in serum/plasma	24 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	TNF-alpha measured in serum/plasma.	Pre-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-6 measured in serum/plasma.	Pre-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-1B measured in serum/plasma.	Pre-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-10 measured in serum/plasma.	Pre-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	TNF-alpha measured in serum/plasma.	5 minutes post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-6 measured in serum/plasma.	5 minutes post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-1B measured in serum/plasma.	5 minutes post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-10 measured in serum/plasma.	5 minutes post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	TNF-alpha measured in serum/plasma.	1 hour post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-6 measured in serum/plasma.	1 hour post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-1B measured in serum/plasma.	1 hour post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-10 measured in serum/plasma.	1 hour post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	TNF-alpha measured in serum/plasma.	4 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-6 measured in serum/plasma.	4 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-1B measured in serum/plasma.	4 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-10 measured in serum/plasma.	4 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	TNF-alpha measured in serum/plasma.	24 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-6 measured in serum/plasma.	24 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-1B measured in serum/plasma.	24 hours post-exercise
Primary	Systemic Inflammation - Serum/Plasma Cytokines	IL-10 measured in serum/plasma.	24 hours post-exercise
Primary	Systemic inflammation - Immune Cells	Leukocytes measured via flow cytometry	Pre-exercise
Primary	Systemic inflammation - Immune Cells	Leukocytes measured via flow cytometry	1 hour post-exercise
Primary	Systemic inflammation - Immune Cells	Leukocytes measured via flow cytometry	4 hours post-exercise
Primary	Systemic inflammation - Immune Cells	Leukocytes measured via flow cytometry	24 hours post-exercise
Secondary	Muscle soreness	Muscle soreness rated on a 0-5 scale.	Pre-exercise
Secondary	Muscle soreness	Muscle soreness rated on a 0-5 scale.	5 minutes post-exercise
Secondary	Muscle soreness	Muscle soreness rated on a 0-5 scale.	4 hours post-exercise
Secondary	Muscle soreness	Muscle soreness rated on a 0-5 scale.	24 hours post-exercise
Secondary	Performance - Jump Height	Vertical jump height measured using a counter movement jump technique.	Pre-exercise
Secondary	Performance - Jump Height	Vertical jump height measured using a counter movement jump technique.	5 minutes post-exercise
Secondary	Performance - Jump Height	Vertical jump height measured using a counter movement jump technique.	4 hours post-exercise
Secondary	Performance - Jump Height	Vertical jump height measured using a counter movement jump technique.	24 hours post-exercise