Brock Exercise And Supplement Trials (BEAST)

September 15, 2019 updated by: Andrea Josse, Brock University

Effects of Greek Yogurt and Exercise on Muscle Size, Body Composition and Bone Health in Untrained, University-aged Males

This study will analyze the effects of Greek yogurt consumption and an 12 week exercise intervention on muscle size, body composition and bone health in untrained, university-aged males.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction: Previous research has shown the effectiveness of dairy milk and whey protein on increasing muscle size, optimizing body composition and increasing strength in adult males. However, evidence on the use of high protein/Greek yogurt on muscle size, body composition and bone health is limited in this population. Yogurt contains similar muscle and bone supporting nutrients as milk, yet it offers a host of additional benefits including; increased satiety, probiotic cultures, greater stability, increased variety, more affordable and versatile features such as acting as a vehicle for consumption of other healthful foods. The proposed research will investigate the use of Greek yogurt as an effective post-exercise food to promote healthy body composition and bone health changes in young adult males.

Design: Parallel, randomized controlled trial.

Participants: 30 (n=15 YOG, n=15 PLA) healthy, untrained university-aged males.

Methods: Subjects will undergo a 12-week resistance and plyometric training program (exercising 3 days/week). The YOG group will consume a 200g dose (pro= 20g, carbs= 8 grams, ~110 kcals) of plain 0% Greek yogurt, while the PLA group will consume an isoenergetic, protein-void beverage comprised mainly of maltodextrin (pro= 0g, carbs= 26g, ~110 kcals). Each group will consume 3 doses per day (immediately and 1 hour post-exercise, and bedtime). Markers of bone health (CTx and P1NP) will be taken at baseline, 1 week and 12 weeks to determine acute and total changes. Muscle size, body composition, strength, vertical jump height and nutritional diaries will be measured pre and post intervention and habitual diet maintenance will be encouraged throughout the intervention.

Anticipated Results: It is hypothesized that each group will undergo positive changes in the aforementioned measures, however due to the increase in protein and calcium consumption, the yogurt group is predicted to have significantly greater increases in these variables than the placebo group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • St. Catharines, Ontario, Canada, L2S3A1
        • Brock University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Age 18-25 years
  • Normal BMI (18.5-24.9) kg/m2
  • Have not participated in a resistance training program (of resistance exercise at least 2x/week or more) in the last 6 months
  • Healthy and not taking any medication affecting muscle or bone
  • Not supplementing with vitamins/ minerals or protein
  • Speak and understand English
  • No dairy allergy or lactose intolerance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Yogurt Group
Group will be consuming 200g of Greek Yogurt (Plain, 0%) 3 times daily for 12 weeks
Behavioral: Resistance and Plyometric Exercise
12 weeks of Resistance (twice weekly) and Plyometric (once weekly) training
Dietary supplement: Greek Yogurt (0% Plain)
200g 3x/day for 12 weeks.
PLACEBO_COMPARATOR: Study Designed Supplement Group
Group will consume an isoenergetic, protein void, maltodextrin-based placebo supplement during the same time points for 12 weeks as well. The Placebo contain maltodextrin and pudding powder to mimic the consistency of Greek yogurt.
Behavioral: Resistance and Plyometric Exercise
12 weeks of Resistance (twice weekly) and Plyometric (once weekly) training
Dietary supplement: Placebo - Study Designed Supplement
Iso-energetic to yogurt. 3x/day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscular Strength
Time Frame: Change from Baseline to 12 weeks
1 Repetition Maximum of bench press, seated row, quad extension and hamstring curl
Change from Baseline to 12 weeks
Muscle Size
Time Frame: Change from Baseline to 12 weeks
Muscle Size determined by ultrasound at various sites.
Change from Baseline to 12 weeks
Body Composition
Time Frame: Change from Baseline to 12 weeks
Body Fat % measured via BodPod and BodyMetrix
Change from Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone cell activity
Time Frame: Change from Baseline to 12 weeks
Bone markers measured in serum.
Change from Baseline to 12 weeks
Vertical Jump Height
Time Frame: Change from Baseline to 12 weeks
measured via chalk-on-wall technique
Change from Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brock University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB16-295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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