AzTrials
AzTrials

HealthyCre-Ex-InfNCT03615989

The Combined Effect of Dairy and Exercise on Bone and Inflammation

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy, Females, Bone
What is being tested?
Resistance and Plyometric 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
13 participants
Where
1 siteCanada
Study dates
1 Oct 2018to 14 Mar 2020
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
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • York University

    Toronto, Ontario, M3J 1P3

Other trials in Canada

About this study

Official title: Does Milk Augment the Acute Effect of Exercise on Bone Turnover and Inflammation

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

Read the detailed description

Introduction: Two million individuals at a cost of around 2.3 billion dollars a year in Canada suffer from osteoporosis. Research that emphasizes the treatment of this disease is important, but so is research that focuses on prevention; reducing bone loss and/or increasing bone mass when young. In addition, inflammation is an issue as it strongly relates to chronic disease. Countermeasures to improve bone health and inflammation, such as nutrition and exercise, should be explored and implemented. The proposed research combines both nutrition and exercise along with the assessment of bone turnover markers and inflammation in healthy young females, and aims to determine whether dairy versus a carbohydrate-based beverage positively impacts acute bone turnover and the inflammatory response following a bout of resistance and plyometric exercise.

Design: Randomized controlled crossover trial.

Participants: 13 healthy university aged females.

Methods: Participants were asked to complete 2 different acute exercise and nutritional supplement trials. Each trial will be assigned in random order. The two trials were: 1) exercise+carbohydrate (CHO), and 2) exercise+milk (Milk). The whole study, per participant, took a maximum of 8-12 weeks to complete as each supplement trial was separated by ~4 weeks. Each treatment is outlined below.

**DUE TO COVID-19, we removed the treatment trial which involved milk+creatine supplementation. Despite randomization, and before the trial was closed, only 11 participants completed this trial****

Anticipated Results: The investigators anticipate that dairy and exercise will have a greater positive impact on acute bone cell activity and inflammation in healthy young females compared to exercise and CHO.

Being tested
Resistance and Plyometric Exercise, Carbohydrate (Maltodextrin powder mixed with water), Skim Milk
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.

  • Resistance and Plyometric ExerciseBehavioural

    A single resistance and plyometric exercise bout per trial.

  • Carbohydrate (Maltodextrin powder mixed with water)Dietary supplement

    Also called CHO

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

  • Skim MilkDietary supplement

    Also called Milk

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

Study groups in NCT03615989
Study groupRoleWhat they receive
Exercise and Carbohydrate (CHO)Placebo comparatorParticipants 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.
Receives: Behavioral: Resistance and Plyometric Exercise; Dietary Supplement: Carbohydrate (Maltodextrin powder mixed with water)
Exercise and Milk (Milk)ExperimentalParticipants 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.
Receives: Behavioral: Resistance and Plyometric Exercise; Dietary Supplement: Skim Milk

What is being measured

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

  1. Acute Bone Cell Activity

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

    Measured: Baseline

  2. Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    Measured: Baseline

  3. Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    Measured: Baseline

  4. Acute Bone Cell Activity

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

    Measured: 5 minutes post exercise

  5. Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    Measured: 5 minutes post exercise

  6. Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    Measured: 5 minutes post exercise

  7. Acute Bone Cell Activity

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

    Measured: 1 hour post exercise

  8. Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    Measured: 1 hour post exercise

  9. Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    Measured: 1 hour post exercise

  10. Acute Bone Cell Activity

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

    Measured: 24 hours post exercise

  11. Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    Measured: 24 hours post exercise

  12. Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    Measured: 24 hours post exercise

  13. Acute Bone Cell Activity

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

    Measured: 48 hours post exercise

  14. Acute Bone Cell Activity

    Bone markers (SOST) measured in serum/plasma.

    Measured: 48 hours post exercise

  15. Acute Bone Cell Activity

    Bone markers (CTX) measured in serum/plasma.

    Measured: 48 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 posted6 Aug 2018
  2. Study start1 Oct 2018
  3. Primary completion14 Mar 2020
  4. Study completion14 Mar 2020

Why it stopped: COVID-19

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized acute Crossover Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615989
Sponsor's protocol ID
2019-045
Other IDs
REB 17-402
Acronym
Cre-Ex-Inf
Status last verified
May 2021
First submitted
30 Jul 2018
Last updated
18 May 2021
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 Resistance and Plyometric Exercise, Carbohydrate (Maltodextrin powder mixed with water) and Skim Milk in people with Healthy and Females, 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 0 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: stopped early, as of the sponsor's last update on 18 May 2021. 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 was stopped early (reason given: COVID-19). Results are not available in the source record.

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 Cell Activity (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03615989.

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 18 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in