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

Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Healthy; Bone
• Intervention / Treatment: Behavioral: High-Intensity Exercise; Dietary supplement: Greek yogurt; Dietary supplement: Skim Milk; Dietary supplement: Carbohydrate (Maltodextrin powder mixed with water); Dietary supplement: 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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea R Josse, PhD; Phone Number: 30038 1-416-736-2100; Email: ajosse@yorku.ca
• Study Contact Backup: Name: Emily C Fraschetti, MSc; Email: ecfrasch@yorku.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3J1P3
      • Recruiting
      • York University
      • Contact: Andrea R Josse, PhD; Phone Number: 30038 1-(416)-736-2100; Email: ajosse@yorku.ca
      • Contact: Emily C Fraschetti, MSc; Phone Number: 33990 1-(416) 736-2100; Email: ecfrasch@yorku.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and Greek Yogurt (GY); 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; A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.; Dietary supplement: Greek yogurt; 200g consumed immediately after exercise and 1h after exercise.; Other Names: GY
Experimental: Exercise and Milk (Milk); 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; A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.; Dietary supplement: Skim Milk; 500ml consumed immediately after exercise and 1h after exercise.; Other Names: Milk
Active Comparator: Exercise and Carbohydrate (CHO); 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; 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.; Other Names: CHO
Placebo Comparator: Exercise and Water (W); 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; A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.; Dietary supplement: Water; 500ml consumed immediately after exercise and 1h after exercise.; Other Names: W

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: York University
• Investigators: Principal Investigator: Andrea R Josse, PhD, York University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Exercise; Dairy; Bone health; Females
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2019-045b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No