Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response

Conditions
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Healthy, Bone, Inflammation

Intervention / Treatment
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* Behavioral: High-Intensity Exercise
* Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)
* Dietary Supplement: Skim Milk
* Dietary Supplement: Greek yogurt
* Dietary Supplement: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and Greek Yogurt (GY)<br>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume  200g Greek yogurt (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional  200g of Greek yogurt. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise. | Behavioral: High-Intensity Exercise<br>* A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.<br>Dietary Supplement: Greek yogurt<br>* 200g consumed immediately after exercise and 1h after exercise.<br>* Other names: GY;|
| Experimental: Exercise and Milk (Milk)<br>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume  500ml plain skim milk (0% milk fat). An additional blood sample will be taken at 1h post-exercise, followed by an additional  500ml of skim milk. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise. | Behavioral: High-Intensity Exercise<br>* A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.<br>Dietary Supplement: Skim Milk<br>* 500ml consumed immediately after exercise and 1h after exercise.<br>* Other names: Milk;|
| Active Comparator: Exercise and Carbohydrate (CHO)<br>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume  50g of maltodextrin mixed with water ( 500ml). An additional blood sample will be taken at 1h post-exercise, followed by an additional  500ml of the maltodextrin drink. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise. | Behavioral: High-Intensity Exercise<br>* A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.<br>Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)<br>* 50g consumed immediately after exercise and 1h after exercise.<br>* Other names: CHO;|
| Placebo Comparator: Exercise and Water (W)<br>Participants will have a fasted baseline blood sample taken upon arrival to the lab. Then they will take part in a high-intensity exercise protocol, consisting of high-intensity interval cycling, resistance exercise, and plyometrics. Following exercise, participants will return to the lab for a 5min post-exercise blood sample, and then consume  500ml water. An additional blood sample will be taken at 1h post-exercise, followed by an additional  500ml water. Blood samples will also be taken at 4h and 24h post-exercise. Participants will also rate their muscle soreness and perform a jump height test at pre-exercise, 5min post-exercise, 4h and 24h post-exercise. | Behavioral: High-Intensity Exercise<br>* A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.<br>Dietary Supplement: Water<br>* 500ml consumed immediately after exercise and 1h after exercise.<br>* Other names: W;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Bone Turnover/Cell Activity | OPG measured in serum/plasma | Pre-exercise | 
| Acute Bone Turnover/Cell Activity | RANKL measured in serum/plasma | Pre-exercise | 
| Acute Bone Turnover/Cell Activity | OC measured in serum/plasma | Pre-exercise | 
| Acute Bone Turnover/Cell Activity | SOST measured in serum/plasma | Pre-exercise | 
| Acute Bone Turnover/Cell Activity | CTX measured in serum/plasma | Pre-exercise | 
| Acute Bone Turnover/Cell Activity | OPG measured in serum/plasma | 5 minutes post-exercise | 
| Acute Bone Turnover/Cell Activity | RANKL measured in serum/plasma | 5 minutes post-exercise | 
| Acute Bone Turnover/Cell Activity | OC measured in serum/plasma | 5 minutes post-exercise | 
| Acute Bone Turnover/Cell Activity | SOST measured in serum/plasma | 5 minutes post-exercise | 
| Acute Bone Turnover/Cell Activity | CTX measured in serum/plasma | 5 minutes post-exercise | 
| Acute Bone Turnover/Cell Activity | OPG measured in serum/plasma | 1 hour post-exercise | 
| Acute Bone Turnover/Cell Activity | RANKL measured in serum/plasma | 1 hour post-exercise | 
| Acute Bone Turnover/Cell Activity | OC measured in serum/plasma | 1 hour post-exercise | 
| Acute Bone Turnover/Cell Activity | SOST measured in serum/plasma | 1 hour post-exercise | 
| Acute Bone Turnover/Cell Activity | CTX measured in serum/plasma | 1 hour post-exercise | 
| Acute Bone Turnover/Cell Activity | OPG measured in serum/plasma | 4 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | RANKL measured in serum/plasma | 4 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | OC measured in serum/plasma | 4 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | SOST measured in serum/plasma | 4 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | CTX measured in serum/plasma | 4 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | OPG measured in serum/plasma | 24 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | RANKL measured in serum/plasma | 24 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | OC measured in serum/plasma | 24 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | SOST measured in serum/plasma | 24 hours post-exercise | 
| Acute Bone Turnover/Cell Activity | CTX measured in serum/plasma | 24 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | TNF-alpha measured in serum/plasma. | Pre-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-6 measured in serum/plasma. | Pre-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-1B measured in serum/plasma. | Pre-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-10 measured in serum/plasma. | Pre-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | TNF-alpha measured in serum/plasma. | 5 minutes post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-6 measured in serum/plasma. | 5 minutes post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-1B measured in serum/plasma. | 5 minutes post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-10 measured in serum/plasma. | 5 minutes post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | TNF-alpha measured in serum/plasma. | 1 hour post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-6 measured in serum/plasma. | 1 hour post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-1B measured in serum/plasma. | 1 hour post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-10 measured in serum/plasma. | 1 hour post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | TNF-alpha measured in serum/plasma. | 4 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-6 measured in serum/plasma. | 4 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-1B measured in serum/plasma. | 4 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-10 measured in serum/plasma. | 4 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | TNF-alpha measured in serum/plasma. | 24 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-6 measured in serum/plasma. | 24 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-1B measured in serum/plasma. | 24 hours post-exercise | 
| Systemic Inflammation - Serum/Plasma Cytokines | IL-10 measured in serum/plasma. | 24 hours post-exercise | 
| Systemic inflammation - Immune Cells | Leukocytes measured via flow cytometry | Pre-exercise | 
| Systemic inflammation - Immune Cells | Leukocytes measured via flow cytometry | 1 hour post-exercise | 
| Systemic inflammation - Immune Cells | Leukocytes measured via flow cytometry | 4 hours post-exercise | 
| Systemic inflammation - Immune Cells | Leukocytes measured via flow cytometry | 24 hours post-exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle soreness | Muscle soreness rated on a 0-5 scale. | Pre-exercise | 
| Muscle soreness | Muscle soreness rated on a 0-5 scale. | 5 minutes post-exercise | 
| Muscle soreness | Muscle soreness rated on a 0-5 scale. | 4 hours post-exercise | 
| Muscle soreness | Muscle soreness rated on a 0-5 scale. | 24 hours post-exercise | 
| Performance - Jump Height | Vertical jump height measured using a counter movement jump technique. | Pre-exercise | 
| Performance - Jump Height | Vertical jump height measured using a counter movement jump technique. | 5 minutes post-exercise | 
| Performance - Jump Height | Vertical jump height measured using a counter movement jump technique. | 4 hours post-exercise | 
| Performance - Jump Height | Vertical jump height measured using a counter movement jump technique. | 24 hours post-exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone health, Females, Dairy, Exercise, Inflammation