UntrainedBEASTNCT03196856
Brock Exercise And Supplement Trials
A study testing Resistance and Plyometric Exercise and Greek Yogurt (0% Plain) in people with Untrained and Healthy, run by Brock University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- What is being tested?
- Resistance and Plyometric Exercise and Greek Yogurt (0% Plain)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 30 May 2019
- 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Resistance and Plyometric Exercise, Greek Yogurt (0% Plain), Placebo - Study Designed Supplement
- Keywords
- Greek Yogurt, Muscle Size, Bone Health, Body Composition, Exercise
- Medical subject headings
- 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
12 weeks of Resistance (twice weekly) and Plyometric (once weekly) training
Greek Yogurt (0% Plain)Dietary supplement
200g 3x/day for 12 weeks.
Placebo - Study Designed SupplementDietary supplement
Iso-energetic to yogurt. 3x/day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yogurt Group | Experimental | Group will be consuming 200g of Greek Yogurt (Plain, 0%) 3 times daily for 12 weeks Receives: Behavioral: Resistance and Plyometric Exercise; Dietary Supplement: Greek Yogurt (0% Plain) |
| Study Designed Supplement Group | Placebo comparator | 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. Receives: Behavioral: Resistance and Plyometric Exercise; Dietary Supplement: Placebo - Study Designed Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular Strength
1 Repetition Maximum of bench press, seated row, quad extension and hamstring curl
Measured: Change from Baseline to 12 weeks
Muscle Size
Muscle Size determined by ultrasound at various sites.
Measured: Change from Baseline to 12 weeks
Body Composition
Body Fat % measured via BodPod and BodyMetrix
Measured: Change from Baseline to 12 weeks
Secondary outcomes (2)
Bone cell activity
Bone markers measured in serum.
Measured: Change from Baseline to 12 weeks
Vertical Jump Height
measured via chalk-on-wall technique
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Aug 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UntrainedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Josse, Brock University
- Investigators
- Andrea Josse, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196856
- Sponsor's protocol ID
- REB16-295
- Acronym
- BEAST
- Status last verified
- Sep 2019
- First submitted
- 14 Jun 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bridge A, Brown J, Snider H, Nasato M, Ward WE, Roy BD, Josse AR. Greek Yogurt and 12 Weeks of Exercise Training on Strength, Muscle Thickness and Body Composition in Lean, Untrained, University-Aged Males. Front Nutr. 2019 Apr 30;6:55. doi: 10.3389/fnut.2019.00055. eCollection 2019.
PubMed 31114790
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Greek Yogurt and Exercise on Muscle Size, Body Composition and Bone Health in Untrained, University-aged Males
- ClinicalTrials.gov ID
- NCT03196856
- Acronym / sponsor ID
- BEAST / REB16-295
- Keywords
- Greek Yogurt, Muscle Size, Bone Health, Body Composition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Yogurt Group | Experimental | Behavioral: Resistance and Plyometric Exercise, Dietary Supplement: Greek Yogurt (0% Plain)Group will be consuming 200g of Greek Yogurt (Plain, 0%) 3 times daily for 12 weeks |
| Study Designed Supplement Group | Placebo comparator | Behavioral: Resistance and Plyometric Exercise, Dietary Supplement: Placebo - Study Designed SupplementGroup 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance and Plyometric Exercise12 weeks of Resistance (twice weekly) and Plyometric (once weekly) training | Behavioural | Study Designed Supplement Group, Yogurt Group |
| Greek Yogurt (0% Plain)200g 3x/day for 12 weeks. | Dietary supplement | Yogurt Group |
| Placebo - Study Designed SupplementIso-energetic to yogurt. 3x/day for 12 weeks. | Dietary supplement | Study Designed Supplement Group |
Primary outcome
Muscular Strength
Time frame: Change from Baseline to 12 weeks
1 Repetition Maximum of bench press, seated row, quad extension and hamstring curl
Muscle Size
Time frame: Change from Baseline to 12 weeks
Muscle Size determined by ultrasound at various sites.
Body Composition
Time frame: Change from Baseline to 12 weeks
Body Fat % measured via BodPod and BodyMetrix
2 secondary outcomes
Bone cell activity
Time frame: Change from Baseline to 12 weeks
Vertical Jump Height
Time frame: Change from Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Results publication: PubMed 31114790Bridge A, Brown J, Snider H, Nasato M, Ward WE, Roy BD, Josse AR. Greek Yogurt and 12 Weeks of Exercise Training on Strength, Muscle Thickness and Body Composition in Lean, Untrained, University-Aged Males. Front Nutr. 2019 Apr 30;6:55. doi: 10.3389/fnut.2019.00055. eCollection 2019.
- Published ManuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Josse, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance and Plyometric Exercise and Greek Yogurt (0% Plain) in people with Untrained and Healthy, run by Brock 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 8 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: finished, as of the sponsor's last update on 17 Sep 2019. 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?
Muscular Strength (time frame: Change from Baseline to 12 weeks). The study lists 3 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 NCT03196856, which also lists 1 linked publication.
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 17 Sep 2019.