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HealthyBIONEXNCT06041087

Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

A study testing High-Intensity Exercise, Carbohydrate (Maltodextrin powder mixed with water) and Skim Milk in people with Healthy and Bone, run by York University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Bone, Inflammation
What is being tested?
High-Intensity Exercise, Carbohydrate (Maltodextrin powder mixed with water) and Skim Milk
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteCanada
Study dates
1 Nov 2023to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis)
  • Any chronic condition, inflammatory, or auto-immune condition

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • York University

    Toronto, Ontario, M3J1P3

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
High-Intensity Exercise, Carbohydrate (Maltodextrin powder mixed with water), Skim Milk, Greek yogurt, Water
Keywords
Bone health, Females, Dairy, Exercise, Inflammation
Medical subject headings
Inflammation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Intensity ExerciseBehavioural

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

  • Carbohydrate (Maltodextrin powder mixed with water)Dietary supplement

    Also called CHO

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

  • Skim MilkDietary supplement

    Also called Milk

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

  • Greek yogurtDietary supplement

    Also called GY

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

  • WaterDietary supplement

    Also called W

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

Study groups in NCT06041087
Study groupRoleWhat they receive
Exercise and Greek Yogurt (GY)ExperimentalParticipants 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.
Receives: Behavioral: High-Intensity Exercise; Dietary Supplement: Greek yogurt
Exercise and Milk (Milk)ExperimentalParticipants 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.
Receives: Behavioral: High-Intensity Exercise; Dietary Supplement: Skim Milk
Exercise and Carbohydrate (CHO)Active comparatorParticipants 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.
Receives: Behavioral: High-Intensity Exercise; Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)
Exercise and Water (W)Placebo comparatorParticipants 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.
Receives: Behavioral: High-Intensity Exercise; Dietary Supplement: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Bone Turnover/Cell Activity

    OPG measured in serum/plasma

    Measured: Pre-exercise

  2. Acute Bone Turnover/Cell Activity

    RANKL measured in serum/plasma

    Measured: Pre-exercise

  3. Acute Bone Turnover/Cell Activity

    OC measured in serum/plasma

    Measured: Pre-exercise

  4. Acute Bone Turnover/Cell Activity

    SOST measured in serum/plasma

    Measured: Pre-exercise

  5. Acute Bone Turnover/Cell Activity

    CTX measured in serum/plasma

    Measured: Pre-exercise

  6. Acute Bone Turnover/Cell Activity

    OPG measured in serum/plasma

    Measured: 5 minutes post-exercise

  7. Acute Bone Turnover/Cell Activity

    RANKL measured in serum/plasma

    Measured: 5 minutes post-exercise

  8. Acute Bone Turnover/Cell Activity

    OC measured in serum/plasma

    Measured: 5 minutes post-exercise

  9. Acute Bone Turnover/Cell Activity

    SOST measured in serum/plasma

    Measured: 5 minutes post-exercise

  10. Acute Bone Turnover/Cell Activity

    CTX measured in serum/plasma

    Measured: 5 minutes post-exercise

  11. Acute Bone Turnover/Cell Activity

    OPG measured in serum/plasma

    Measured: 1 hour post-exercise

  12. Acute Bone Turnover/Cell Activity

    RANKL measured in serum/plasma

    Measured: 1 hour post-exercise

  13. Acute Bone Turnover/Cell Activity

    OC measured in serum/plasma

    Measured: 1 hour post-exercise

  14. Acute Bone Turnover/Cell Activity

    SOST measured in serum/plasma

    Measured: 1 hour post-exercise

  15. Acute Bone Turnover/Cell Activity

    CTX measured in serum/plasma

    Measured: 1 hour post-exercise

  16. Acute Bone Turnover/Cell Activity

    OPG measured in serum/plasma

    Measured: 4 hours post-exercise

  17. Acute Bone Turnover/Cell Activity

    RANKL measured in serum/plasma

    Measured: 4 hours post-exercise

  18. Acute Bone Turnover/Cell Activity

    OC measured in serum/plasma

    Measured: 4 hours post-exercise

  19. Acute Bone Turnover/Cell Activity

    SOST measured in serum/plasma

    Measured: 4 hours post-exercise

  20. Acute Bone Turnover/Cell Activity

    CTX measured in serum/plasma

    Measured: 4 hours post-exercise

  21. Acute Bone Turnover/Cell Activity

    OPG measured in serum/plasma

    Measured: 24 hours post-exercise

  22. Acute Bone Turnover/Cell Activity

    RANKL measured in serum/plasma

    Measured: 24 hours post-exercise

  23. Acute Bone Turnover/Cell Activity

    OC measured in serum/plasma

    Measured: 24 hours post-exercise

  24. Acute Bone Turnover/Cell Activity

    SOST measured in serum/plasma

    Measured: 24 hours post-exercise

  25. Acute Bone Turnover/Cell Activity

    CTX measured in serum/plasma

    Measured: 24 hours post-exercise

  26. Systemic Inflammation - Serum/Plasma Cytokines

    TNF-alpha measured in serum/plasma.

    Measured: Pre-exercise

  27. Systemic Inflammation - Serum/Plasma Cytokines

    IL-6 measured in serum/plasma.

    Measured: Pre-exercise

  28. Systemic Inflammation - Serum/Plasma Cytokines

    IL-1B measured in serum/plasma.

    Measured: Pre-exercise

  29. Systemic Inflammation - Serum/Plasma Cytokines

    IL-10 measured in serum/plasma.

    Measured: Pre-exercise

  30. Systemic Inflammation - Serum/Plasma Cytokines

    TNF-alpha measured in serum/plasma.

    Measured: 5 minutes post-exercise

  31. Systemic Inflammation - Serum/Plasma Cytokines

    IL-6 measured in serum/plasma.

    Measured: 5 minutes post-exercise

  32. Systemic Inflammation - Serum/Plasma Cytokines

    IL-1B measured in serum/plasma.

    Measured: 5 minutes post-exercise

  33. Systemic Inflammation - Serum/Plasma Cytokines

    IL-10 measured in serum/plasma.

    Measured: 5 minutes post-exercise

  34. Systemic Inflammation - Serum/Plasma Cytokines

    TNF-alpha measured in serum/plasma.

    Measured: 1 hour post-exercise

  35. Systemic Inflammation - Serum/Plasma Cytokines

    IL-6 measured in serum/plasma.

    Measured: 1 hour post-exercise

  36. Systemic Inflammation - Serum/Plasma Cytokines

    IL-1B measured in serum/plasma.

    Measured: 1 hour post-exercise

  37. Systemic Inflammation - Serum/Plasma Cytokines

    IL-10 measured in serum/plasma.

    Measured: 1 hour post-exercise

  38. Systemic Inflammation - Serum/Plasma Cytokines

    TNF-alpha measured in serum/plasma.

    Measured: 4 hours post-exercise

  39. Systemic Inflammation - Serum/Plasma Cytokines

    IL-6 measured in serum/plasma.

    Measured: 4 hours post-exercise

  40. Systemic Inflammation - Serum/Plasma Cytokines

    IL-1B measured in serum/plasma.

    Measured: 4 hours post-exercise

  41. Systemic Inflammation - Serum/Plasma Cytokines

    IL-10 measured in serum/plasma.

    Measured: 4 hours post-exercise

  42. Systemic Inflammation - Serum/Plasma Cytokines

    TNF-alpha measured in serum/plasma.

    Measured: 24 hours post-exercise

  43. Systemic Inflammation - Serum/Plasma Cytokines

    IL-6 measured in serum/plasma.

    Measured: 24 hours post-exercise

  44. Systemic Inflammation - Serum/Plasma Cytokines

    IL-1B measured in serum/plasma.

    Measured: 24 hours post-exercise

  45. Systemic Inflammation - Serum/Plasma Cytokines

    IL-10 measured in serum/plasma.

    Measured: 24 hours post-exercise

  46. Systemic inflammation - Immune Cells

    Leukocytes measured via flow cytometry

    Measured: Pre-exercise

  47. Systemic inflammation - Immune Cells

    Leukocytes measured via flow cytometry

    Measured: 1 hour post-exercise

  48. Systemic inflammation - Immune Cells

    Leukocytes measured via flow cytometry

    Measured: 4 hours post-exercise

  49. Systemic inflammation - Immune Cells

    Leukocytes measured via flow cytometry

    Measured: 24 hours post-exercise

Secondary outcomes (8)
  1. Muscle soreness

    Muscle soreness rated on a 0-5 scale.

    Measured: Pre-exercise

  2. Muscle soreness

    Muscle soreness rated on a 0-5 scale.

    Measured: 5 minutes post-exercise

  3. Muscle soreness

    Muscle soreness rated on a 0-5 scale.

    Measured: 4 hours post-exercise

  4. Muscle soreness

    Muscle soreness rated on a 0-5 scale.

    Measured: 24 hours post-exercise

  5. Performance - Jump Height

    Vertical jump height measured using a counter movement jump technique.

    Measured: Pre-exercise

  6. Performance - Jump Height

    Vertical jump height measured using a counter movement jump technique.

    Measured: 5 minutes post-exercise

  7. Performance - Jump Height

    Vertical jump height measured using a counter movement jump technique.

    Measured: 4 hours post-exercise

  8. Performance - Jump Height

    Vertical jump height measured using a counter movement jump technique.

    Measured: 24 hours post-exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start1 Nov 2023
  3. Primary completion30 Apr 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06041087
Sponsor's protocol ID
2019-045b
Acronym
BIONEX
Status last verified
Jan 2026
First submitted
25 Aug 2023
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-Intensity Exercise, Carbohydrate (Maltodextrin powder mixed with water) and Skim Milk in people with Healthy and Bone, run by York University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Bone Turnover/Cell Activity (time frame: Pre-exercise). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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BIONEX Clinical Trial NCT06041087 | AzTrials