BEAST: Brock Exercise And Supplement Trials

• Sponsor: Brock University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03196856
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Untrained; Healthy	Behavioral: Resistance and Plyometric Exercise; Dietary Supplement: Greek Yogurt (0% Plain); Dietary Supplement: Placebo - Study Designed Supplement	N/A

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

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled TrialRandomized Controlled Trial
• Masking: None (Open Label)
• Masking Description: Participants will be randomly selected to the yogurt group or a placebo group. Although participants within the yogurt group will be aware that they are consuming yogurt, the placebo group will not be aware of the contents of the placebo supplement.
• Primary Purpose: Treatment
• Official Title: Effects of Greek Yogurt and Exercise on Muscle Size, Body Composition and Bone Health in Untrained, University-aged Males
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Aug 30, 2018
• Actual Study Completion Date: May 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Muscular Strength [Change from Baseline to 12 weeks]

   1 Repetition Maximum of bench press, seated row, quad extension and hamstring curl

2. Muscle Size [Change from Baseline to 12 weeks]

   Muscle Size determined by ultrasound at various sites.

3. Body Composition [Change from Baseline to 12 weeks]

   Body Fat % measured via BodPod and BodyMetrix

Secondary Outcome Measures

1. Bone cell activity [Change from Baseline to 12 weeks]

   Bone markers measured in serum.

2. Vertical Jump Height [Change from Baseline to 12 weeks]

   measured via chalk-on-wall technique

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brock University	St. Catharines	Ontario	Canada	L2S3A1

Sponsors and Collaborators

• Brock University

Investigators

• Principal Investigator: Andrea Josse, PhD, Brock University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Published Manuscript

Publications

None provided.

• Responsible Party: Andrea Josse, Assistant Professor, Brock University
• ClinicalTrials.gov Identifier: NCT03196856
• Other Study ID Numbers: REB16-295
• First Posted: Jun 23, 2017
• Last Update Posted: Sep 17, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrea Josse, Assistant Professor, Brock University: Greek Yogurt; Muscle Size; Bone Health; Body Composition; Exercise

Study Results

No Results Posted as of Sep 17, 2019