NCT03615989

Brief Summary

This study analyzes whether dairy supplementation positively impacts loading exercise-induced bone cell activity and inflammation in healthy young females.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2020

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1.5 years

First QC Date

July 30, 2018

Last Update Submit

May 13, 2021

Conditions

HealthyFemalesBoneInflammation

Keywords

Bone HealthFemalesDairyExerciseInflammation

Outcome Measures

Primary Outcomes (15)

  • Acute Bone Cell Activity

    Bone markers (OPG, RANKL, OC) measured in serum/plasma.

    Baseline

  • Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    Baseline

  • Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    Baseline

  • Acute Bone Cell Activity

    Bone markers (OPG, RANKL, OC) measured in serum/plasma.

    5 minutes post exercise

  • Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    5 minutes post exercise

  • Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    5 minutes post exercise

  • Acute Bone Cell Activity

    Bone markers (OPG, RANKL, OC) measured in serum/plasma.

    1 hour post exercise

  • Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    1 hour post exercise

  • Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    1 hour post exercise

  • Acute Bone Cell Activity

    Bone markers (OPG, RANKL, OC) measured in serum/plasma.

    24 hours post exercise

  • Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    24 hours post exercise

  • Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    24 hours post exercise

  • Acute Bone Cell Activity

    Bone markers (OPG, RANKL, OC) measured in serum/plasma.

    48 hours post exercise

  • Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    48 hours post exercise

  • Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    48 hours post exercise

Other Outcomes (5)

  • Inflammation

    Baseline

  • Inflammation

    5 minutes post exercise

  • Inflammation

    1 hour post exercise

  • +2 more other outcomes

Study Arms (2)

Exercise and Carbohydrate (CHO)

PLACEBO COMPARATOR

Participants had a fasted, baseline blood sample (10ml) taken upon arrival to the lab. They then completed a supervised resistance and plyometric exercise bout. Immediately following exercise, 50g of carbohydrate (maltodextrin) + water was consumed. Two more blood samples followed the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 50g of carbohydrate was consumed with water 1 hour post exercise. Two more fasting blood samples (10ml) were taken 24 and 48 hours later.

Behavioral: Resistance and Plyometric ExerciseDietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)

Exercise and Milk (Milk)

EXPERIMENTAL

Participants had a fasted, baseline blood sample (10ml) taken upon arrival to the lab. They then completed a supervised resistance and plyometric exercise bout. Immediately following exercise, \~500 ml of skim milk was consumed. Two more blood samples followed the exercise bout at 5 minutes post (10ml) and 1 hour post (10ml). An additional 500 ml of skim milk was consumed 1 hour post exercise. Two more fasting blood samples (10ml) were taken 24 and 48 hours later.

Behavioral: Resistance and Plyometric ExerciseDietary Supplement: Skim Milk

Interventions

Resistance and Plyometric ExerciseBEHAVIORAL

A single resistance and plyometric exercise bout per trial.

Exercise and Carbohydrate (CHO)Exercise and Milk (Milk)
Carbohydrate (Maltodextrin powder mixed with water)DIETARY_SUPPLEMENT

50 grams immediately after exercise bout. 50 grams 1 hour after exercise bout.

Also known as: CHO
Exercise and Carbohydrate (CHO)
Skim MilkDIETARY_SUPPLEMENT

500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.

Also known as: Milk
Exercise and Milk (Milk)

Eligibility Criteria

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

You may qualify if:

  • Female between the ages of 18 and 30 years
  • Normal BMI (18.5-24.9) kg/m2
  • 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 not but with regular mensural cycle)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

Plyometric ExerciseCarbohydratesWaterMilk

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical 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
Masking Details
Those completing the analyses were masked to the treatments.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized acute Crossover Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 6, 2018

Study Start

October 1, 2018

Primary Completion

March 14, 2020

Study Completion

March 14, 2020

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)