Clinical trial NCT06041087: Bone and Inflammatory Outcomes - Nutrition and Exercise Trials
Official title: Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Bone
Inflammation
Keywords: Bone health
Females
Dairy
Exercise
Inflammation
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Bone Turnover/Cell Activity
timeFrame: Pre-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: Pre-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: Pre-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: Pre-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: Pre-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 5 minutes post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 5 minutes post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 5 minutes post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 5 minutes post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 5 minutes post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 1 hour post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 1 hour post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 1 hour post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 1 hour post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 1 hour post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 4 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 4 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 4 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 4 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 4 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 24 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 24 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 24 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 24 hours post-exercise
measure: Acute Bone Turnover/Cell Activity
timeFrame: 24 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: Pre-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: Pre-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: Pre-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: Pre-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 5 minutes post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 5 minutes post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 5 minutes post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 5 minutes post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 1 hour post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 1 hour post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 1 hour post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 1 hour post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 4 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 4 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 4 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 4 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 24 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 24 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 24 hours post-exercise
measure: Systemic Inflammation - Serum/Plasma Cytokines
timeFrame: 24 hours post-exercise
measure: Systemic inflammation - Immune Cells
timeFrame: Pre-exercise
measure: Systemic inflammation - Immune Cells
timeFrame: 1 hour post-exercise
measure: Systemic inflammation - Immune Cells
timeFrame: 4 hours post-exercise
measure: Systemic inflammation - Immune Cells
timeFrame: 24 hours post-exercise
Secondary outcomes:
measure: Muscle soreness
timeFrame: Pre-exercise
measure: Muscle soreness
timeFrame: 5 minutes post-exercise
measure: Muscle soreness
timeFrame: 4 hours post-exercise
measure: Muscle soreness
timeFrame: 24 hours post-exercise
measure: Performance - Jump Height
timeFrame: Pre-exercise
measure: Performance - Jump Height
timeFrame: 5 minutes post-exercise
measure: Performance - Jump Height
timeFrame: 4 hours post-exercise
measure: Performance - Jump Height
timeFrame: 24 hours post-exercise
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Andrea R Josse, PhD
role: PRINCIPAL_INVESTIGATOR
References: