Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

Not Applicable

Recruiting

• Conditions: Healthy; Bone; Inflammation

• Registration Number: NCT06041087
• Lead Sponsor: York University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-18
• Study Start: 2023-11-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Acute Bone Turnover/Cell Activity	24 hours post-exercise	CTX measured in serum/plasma
Systemic inflammation - Immune Cells	24 hours post-exercise	Leukocytes measured via flow cytometry
Systemic Inflammation - Serum/Plasma Cytokines	24 hours post-exercise	IL-10 measured in serum/plasma.

Secondary Outcome Measures

Name	Time	Method
Performance - Jump Height	24 hours post-exercise	Vertical jump height measured using a counter movement jump technique.
Muscle soreness	24 hours post-exercise	Muscle soreness rated on a 0-5 scale.

Trial Locations

Locations (1)

York University; 🇨🇦 Toronto, Ontario, Canada