Bone and Inflammatory Outcomes - Nutrition and Exercise Trials (BIONEX)

York University

Status: Completed

Conditions: Inflammation; Healthy; Bone

Treatments: Dietary Supplement: Skim Milk; Dietary Supplement: Greek yogurt; Behavioral: High-Intensity Exercise; Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water); Dietary Supplement: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT06041087

2019-045b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 4 patient groups, including a placebo group

Exercise and Greek Yogurt (GY)

Experimental group

Description:

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.

Treatment:

Behavioral: High-Intensity Exercise

Dietary Supplement: Greek yogurt

Exercise and Milk (Milk)

Experimental group

Description:

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.

Treatment:

Behavioral: High-Intensity Exercise

Dietary Supplement: Skim Milk

Exercise and Carbohydrate (CHO)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)

Behavioral: High-Intensity Exercise

Exercise and Water (W)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Water

Behavioral: High-Intensity Exercise