NCT06041087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

August 25, 2023

Last Update Submit

January 14, 2026

Conditions

BoneInflammationHealthy

Keywords

Bone healthFemalesDairyExerciseInflammation

Outcome Measures

Primary Outcomes (49)

  • 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 Outcomes (8)

  • Muscle soreness

    Pre-exercise

  • Muscle soreness

    5 minutes post-exercise

  • Muscle soreness

    4 hours post-exercise

  • Muscle soreness

    24 hours post-exercise

  • Performance - Jump Height

    Pre-exercise

  • +3 more secondary outcomes

Study Arms (4)

Exercise and Greek Yogurt (GY)

EXPERIMENTAL

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 ExerciseDietary Supplement: Greek yogurt

Exercise and Milk (Milk)

EXPERIMENTAL

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 ExerciseDietary Supplement: Skim Milk

Exercise and Carbohydrate (CHO)

ACTIVE COMPARATOR

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 ExerciseDietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)

Exercise and Water (W)

PLACEBO COMPARATOR

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 ExerciseDietary Supplement: Water

Interventions

Skim MilkDIETARY_SUPPLEMENT

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

Also known as: Milk
Exercise and Milk (Milk)
Greek yogurtDIETARY_SUPPLEMENT

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

Also known as: GY
Exercise and Greek Yogurt (GY)
WaterDIETARY_SUPPLEMENT

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

Also known as: W
Exercise and Water (W)
High-Intensity ExerciseBEHAVIORAL

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

Exercise and Carbohydrate (CHO)Exercise and Greek Yogurt (GY)Exercise and Milk (Milk)Exercise and Water (W)
Carbohydrate (Maltodextrin powder mixed with water)DIETARY_SUPPLEMENT

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

Also known as: CHO
Exercise and Carbohydrate (CHO)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J1P3, Canada

Location

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

High-Intensity Interval TrainingCarbohydratesWaterMilk

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Andrea R Josse, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 18, 2023

Study Start

November 1, 2023

Primary Completion

April 30, 2025

Study Completion

September 1, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)