BIONEX: Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

Sponsor
York University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06041087
Collaborator
(none)
25
1
4
22
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High-Intensity Exercise
  • Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)
  • Dietary Supplement: Skim Milk
  • Dietary Supplement: Greek yogurt
  • Dietary Supplement: Water
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Dairy Supplementation and the Post-Exercise Bone and Inflammatory Response
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Acute Bone Turnover/Cell Activity [Pre-exercise]

      OPG measured in serum/plasma

    2. Acute Bone Turnover/Cell Activity [Pre-exercise]

      RANKL measured in serum/plasma

    3. Acute Bone Turnover/Cell Activity [Pre-exercise]

      OC measured in serum/plasma

    4. Acute Bone Turnover/Cell Activity [Pre-exercise]

      SOST measured in serum/plasma

    5. Acute Bone Turnover/Cell Activity [Pre-exercise]

      CTX measured in serum/plasma

    6. Acute Bone Turnover/Cell Activity [5 minutes post-exercise]

      OPG measured in serum/plasma

    7. Acute Bone Turnover/Cell Activity [5 minutes post-exercise]

      RANKL measured in serum/plasma

    8. Acute Bone Turnover/Cell Activity [5 minutes post-exercise]

      OC measured in serum/plasma

    9. Acute Bone Turnover/Cell Activity [5 minutes post-exercise]

      SOST measured in serum/plasma

    10. Acute Bone Turnover/Cell Activity [5 minutes post-exercise]

      CTX measured in serum/plasma

    11. Acute Bone Turnover/Cell Activity [1 hour post-exercise]

      OPG measured in serum/plasma

    12. Acute Bone Turnover/Cell Activity [1 hour post-exercise]

      RANKL measured in serum/plasma

    13. Acute Bone Turnover/Cell Activity [1 hour post-exercise]

      OC measured in serum/plasma

    14. Acute Bone Turnover/Cell Activity [1 hour post-exercise]

      SOST measured in serum/plasma

    15. Acute Bone Turnover/Cell Activity [1 hour post-exercise]

      CTX measured in serum/plasma

    16. Acute Bone Turnover/Cell Activity [4 hours post-exercise]

      OPG measured in serum/plasma

    17. Acute Bone Turnover/Cell Activity [4 hours post-exercise]

      RANKL measured in serum/plasma

    18. Acute Bone Turnover/Cell Activity [4 hours post-exercise]

      OC measured in serum/plasma

    19. Acute Bone Turnover/Cell Activity [4 hours post-exercise]

      SOST measured in serum/plasma

    20. Acute Bone Turnover/Cell Activity [4 hours post-exercise]

      CTX measured in serum/plasma

    21. Acute Bone Turnover/Cell Activity [24 hours post-exercise]

      OPG measured in serum/plasma

    22. Acute Bone Turnover/Cell Activity [24 hours post-exercise]

      RANKL measured in serum/plasma

    23. Acute Bone Turnover/Cell Activity [24 hours post-exercise]

      OC measured in serum/plasma

    24. Acute Bone Turnover/Cell Activity [24 hours post-exercise]

      SOST measured in serum/plasma

    25. Acute Bone Turnover/Cell Activity [24 hours post-exercise]

      CTX measured in serum/plasma

    26. Systemic Inflammation - Serum/Plasma Cytokines [Pre-exercise]

      TNF-alpha measured in serum/plasma.

    27. Systemic Inflammation - Serum/Plasma Cytokines [Pre-exercise]

      IL-6 measured in serum/plasma.

    28. Systemic Inflammation - Serum/Plasma Cytokines [Pre-exercise]

      IL-1B measured in serum/plasma.

    29. Systemic Inflammation - Serum/Plasma Cytokines [Pre-exercise]

      IL-10 measured in serum/plasma.

    30. Systemic Inflammation - Serum/Plasma Cytokines [5 minutes post-exercise]

      TNF-alpha measured in serum/plasma.

    31. Systemic Inflammation - Serum/Plasma Cytokines [5 minutes post-exercise]

      IL-6 measured in serum/plasma.

    32. Systemic Inflammation - Serum/Plasma Cytokines [5 minutes post-exercise]

      IL-1B measured in serum/plasma.

    33. Systemic Inflammation - Serum/Plasma Cytokines [5 minutes post-exercise]

      IL-10 measured in serum/plasma.

    34. Systemic Inflammation - Serum/Plasma Cytokines [1 hour post-exercise]

      TNF-alpha measured in serum/plasma.

    35. Systemic Inflammation - Serum/Plasma Cytokines [1 hour post-exercise]

      IL-6 measured in serum/plasma.

    36. Systemic Inflammation - Serum/Plasma Cytokines [1 hour post-exercise]

      IL-1B measured in serum/plasma.

    37. Systemic Inflammation - Serum/Plasma Cytokines [1 hour post-exercise]

      IL-10 measured in serum/plasma.

    38. Systemic Inflammation - Serum/Plasma Cytokines [4 hours post-exercise]

      TNF-alpha measured in serum/plasma.

    39. Systemic Inflammation - Serum/Plasma Cytokines [4 hours post-exercise]

      IL-6 measured in serum/plasma.

    40. Systemic Inflammation - Serum/Plasma Cytokines [4 hours post-exercise]

      IL-1B measured in serum/plasma.

    41. Systemic Inflammation - Serum/Plasma Cytokines [4 hours post-exercise]

      IL-10 measured in serum/plasma.

    42. Systemic Inflammation - Serum/Plasma Cytokines [24 hours post-exercise]

      TNF-alpha measured in serum/plasma.

    43. Systemic Inflammation - Serum/Plasma Cytokines [24 hours post-exercise]

      IL-6 measured in serum/plasma.

    44. Systemic Inflammation - Serum/Plasma Cytokines [24 hours post-exercise]

      IL-1B measured in serum/plasma.

    45. Systemic Inflammation - Serum/Plasma Cytokines [24 hours post-exercise]

      IL-10 measured in serum/plasma.

    46. Systemic inflammation - Immune Cells [Pre-exercise]

      Leukocytes measured via flow cytometry

    47. Systemic inflammation - Immune Cells [1 hour post-exercise]

      Leukocytes measured via flow cytometry

    48. Systemic inflammation - Immune Cells [4 hours post-exercise]

      Leukocytes measured via flow cytometry

    49. Systemic inflammation - Immune Cells [24 hours post-exercise]

      Leukocytes measured via flow cytometry

    Secondary Outcome Measures

    1. Muscle soreness [Pre-exercise]

      Muscle soreness rated on a 0-5 scale.

    2. Muscle soreness [5 minutes post-exercise]

      Muscle soreness rated on a 0-5 scale.

    3. Muscle soreness [4 hours post-exercise]

      Muscle soreness rated on a 0-5 scale.

    4. Muscle soreness [24 hours post-exercise]

      Muscle soreness rated on a 0-5 scale.

    5. Performance - Jump Height [Pre-exercise]

      Vertical jump height measured using a counter movement jump technique.

    6. Performance - Jump Height [5 minutes post-exercise]

      Vertical jump height measured using a counter movement jump technique.

    7. Performance - Jump Height [4 hours post-exercise]

      Vertical jump height measured using a counter movement jump technique.

    8. Performance - Jump Height [24 hours post-exercise]

      Vertical jump height measured using a counter movement jump technique.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 York University Toronto Ontario Canada M3J1P3

    Sponsors and Collaborators

    • York University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Josse, Assistant Professor, York University
    ClinicalTrials.gov Identifier:
    NCT06041087
    Other Study ID Numbers:
    • 2019-045b
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrea Josse, Assistant Professor, York University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2023