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Completed

NCT Number: NCT06041087

Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York University

Toronto, Ontario, M3J1P3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Intensity Exercise

Behavioral

A single bout of high-intensity exercise (cycling intervals, resistance exercise, plyometrics) per trial.

Carbohydrate (Maltodextrin powder mixed with water)

Dietary Supplement

50g consumed immediately after exercise and 1h after exercise.

Other names: CHO

Skim Milk

Dietary Supplement

500ml consumed immediately after exercise and 1h after exercise.

Other names: Milk

Greek yogurt

Dietary Supplement

200g consumed immediately after exercise and 1h after exercise.

Other names: GY

Water

Dietary Supplement

500ml consumed immediately after exercise and 1h after exercise.

Other names: W

Primary outcomes

  1. Acute Bone Turnover/Cell Activity

    Time frame: Pre-exercise

    OPG measured in serum/plasma

  2. Acute Bone Turnover/Cell Activity

    Time frame: Pre-exercise

    RANKL measured in serum/plasma

  3. Acute Bone Turnover/Cell Activity

    Time frame: Pre-exercise

    OC measured in serum/plasma

  4. Acute Bone Turnover/Cell Activity

    Time frame: Pre-exercise

    SOST measured in serum/plasma

  5. Acute Bone Turnover/Cell Activity

    Time frame: Pre-exercise

    CTX measured in serum/plasma

  6. Acute Bone Turnover/Cell Activity

    Time frame: 5 minutes post-exercise

    OPG measured in serum/plasma

  7. Acute Bone Turnover/Cell Activity

    Time frame: 5 minutes post-exercise

    RANKL measured in serum/plasma

  8. Acute Bone Turnover/Cell Activity

    Time frame: 5 minutes post-exercise

    OC measured in serum/plasma

  9. Acute Bone Turnover/Cell Activity

    Time frame: 5 minutes post-exercise

    SOST measured in serum/plasma

  10. Acute Bone Turnover/Cell Activity

    Time frame: 5 minutes post-exercise

    CTX measured in serum/plasma

  11. Acute Bone Turnover/Cell Activity

    Time frame: 1 hour post-exercise

    OPG measured in serum/plasma

  12. Acute Bone Turnover/Cell Activity

    Time frame: 1 hour post-exercise

    RANKL measured in serum/plasma

  13. Acute Bone Turnover/Cell Activity

    Time frame: 1 hour post-exercise

    OC measured in serum/plasma

  14. Acute Bone Turnover/Cell Activity

    Time frame: 1 hour post-exercise

    SOST measured in serum/plasma

  15. Acute Bone Turnover/Cell Activity

    Time frame: 1 hour post-exercise

    CTX measured in serum/plasma

  16. Acute Bone Turnover/Cell Activity

    Time frame: 4 hours post-exercise

    OPG measured in serum/plasma

  17. Acute Bone Turnover/Cell Activity

    Time frame: 4 hours post-exercise

    RANKL measured in serum/plasma

  18. Acute Bone Turnover/Cell Activity

    Time frame: 4 hours post-exercise

    OC measured in serum/plasma

  19. Acute Bone Turnover/Cell Activity

    Time frame: 4 hours post-exercise

    SOST measured in serum/plasma

  20. Acute Bone Turnover/Cell Activity

    Time frame: 4 hours post-exercise

    CTX measured in serum/plasma

  21. Acute Bone Turnover/Cell Activity

    Time frame: 24 hours post-exercise

    OPG measured in serum/plasma

  22. Acute Bone Turnover/Cell Activity

    Time frame: 24 hours post-exercise

    RANKL measured in serum/plasma

  23. Acute Bone Turnover/Cell Activity

    Time frame: 24 hours post-exercise

    OC measured in serum/plasma

  24. Acute Bone Turnover/Cell Activity

    Time frame: 24 hours post-exercise

    SOST measured in serum/plasma

  25. Acute Bone Turnover/Cell Activity

    Time frame: 24 hours post-exercise

    CTX measured in serum/plasma

  26. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: Pre-exercise

    TNF-alpha measured in serum/plasma.

  27. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: Pre-exercise

    IL-6 measured in serum/plasma.

  28. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: Pre-exercise

    IL-1B measured in serum/plasma.

  29. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: Pre-exercise

    IL-10 measured in serum/plasma.

  30. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 5 minutes post-exercise

    TNF-alpha measured in serum/plasma.

  31. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 5 minutes post-exercise

    IL-6 measured in serum/plasma.

  32. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 5 minutes post-exercise

    IL-1B measured in serum/plasma.

  33. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 5 minutes post-exercise

    IL-10 measured in serum/plasma.

  34. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 1 hour post-exercise

    TNF-alpha measured in serum/plasma.

  35. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 1 hour post-exercise

    IL-6 measured in serum/plasma.

  36. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 1 hour post-exercise

    IL-1B measured in serum/plasma.

  37. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 1 hour post-exercise

    IL-10 measured in serum/plasma.

  38. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 4 hours post-exercise

    TNF-alpha measured in serum/plasma.

  39. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 4 hours post-exercise

    IL-6 measured in serum/plasma.

  40. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 4 hours post-exercise

    IL-1B measured in serum/plasma.

  41. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 4 hours post-exercise

    IL-10 measured in serum/plasma.

  42. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 24 hours post-exercise

    TNF-alpha measured in serum/plasma.

  43. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 24 hours post-exercise

    IL-6 measured in serum/plasma.

  44. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 24 hours post-exercise

    IL-1B measured in serum/plasma.

  45. Systemic Inflammation - Serum/Plasma Cytokines

    Time frame: 24 hours post-exercise

    IL-10 measured in serum/plasma.

  46. Systemic inflammation - Immune Cells

    Time frame: Pre-exercise

    Leukocytes measured via flow cytometry

  47. Systemic inflammation - Immune Cells

    Time frame: 1 hour post-exercise

    Leukocytes measured via flow cytometry

  48. Systemic inflammation - Immune Cells

    Time frame: 4 hours post-exercise

    Leukocytes measured via flow cytometry

  49. Systemic inflammation - Immune Cells

    Time frame: 24 hours post-exercise

    Leukocytes measured via flow cytometry

Secondary outcomes

  1. Muscle soreness

    Time frame: Pre-exercise

    Muscle soreness rated on a 0-5 scale.

  2. Muscle soreness

    Time frame: 5 minutes post-exercise

    Muscle soreness rated on a 0-5 scale.

  3. Muscle soreness

    Time frame: 4 hours post-exercise

    Muscle soreness rated on a 0-5 scale.

  4. Muscle soreness

    Time frame: 24 hours post-exercise

    Muscle soreness rated on a 0-5 scale.

  5. Performance - Jump Height

    Time frame: Pre-exercise

    Vertical jump height measured using a counter movement jump technique.

  6. Performance - Jump Height

    Time frame: 5 minutes post-exercise

    Vertical jump height measured using a counter movement jump technique.

  7. Performance - Jump Height

    Time frame: 4 hours post-exercise

    Vertical jump height measured using a counter movement jump technique.

  8. Performance - Jump Height

    Time frame: 24 hours post-exercise

    Vertical jump height measured using a counter movement jump technique.

Sponsors and collaborators

Lead sponsor

York University

Other

Registry information

Official study title

Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response

Acronym: BIONEX

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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