Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength

This study will investigate the effects of a soy/dairy protein blend on muscle growth and strength. In sports nutrition and in aging it is important to have healthy muscles. This can be achieved with exercise and nutrition. Consumption of protein following resistance exercise can promote healthy muscle growth and help improve strength. Young healthy men will be studied during a 12 week resistance exercise training program and be given protein supplements every day during the study. The hypothesis is that a blend of soy, whey and casein will induce a greater muscle gain and strength increase than the control.

Study Overview

• Status: Completed
• Conditions: Muscle
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Blend; Dietary supplement: Whey

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Stable body weight, healthy, males aged 18-35

Exclusion Criteria:

1. Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
2. Resistance Training (>2 weekly sessions of moderate to high intensity) within the past six months
3. Any orthopedic injury that prohibits participation in the exercise training
4. Significant heart, liver, kidney, blood, or respiratory disease
5. Peripheral vascular disease
6. Diabetes mellitus or other untreated endocrine disease
7. Active cancer (all groups) and history of cancer
8. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
10. Alcohol or drug abuse
11. Tobacco use (smoking or chewing)
12. BMI range will be (20-29.9 kg/m2) to exclude for Malnutrition (hypoalbuminemia, and/or hypotransferrinemia) and Obesity
13. Low hemoglobin levels (below normal values)
14. Food allergies (including milk and soy)
15. Individuals on a Vegetarian Diet
16. Females
17. Average protein intake < 0.6 or >1.8 g/kg per day
18. Taking dietary supplements such as green tea, creatine, ribose, whey or soy protein, etc. within the past 6 months
19. Currently on a high-soy diet or high dairy diet (consuming >2 servings of soy per day or >6 servings of dairy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo dry blended beverage (carbohydrate)	Dietary supplement: Placebo; 22 grams of carbohydrate/day
Experimental: Blend; A dry blended beverage containing a protein blend of soy, whey and casein	Dietary supplement: Blend; 22 grams of protein/day
Active Comparator: Whey; A dry blended beverage containing Whey protein	Dietary supplement: Whey; 22 grams of protein/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle Mass	Muscle Mass will be determined by DEXA	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle Strength	Knee Extensor	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: DuPont Nutrition and Health
• Investigators: Principal Investigator: Mark B Cope, PhD, Solae, LLC; Principal Investigator: Blake Rasmussen, PhD, University of Texas

Publications and helpful links

General Publications

• Reidy PT, Fry CS, Igbinigie S, Deer RR, Jennings K, Cope MB, Mukherjea R, Volpi E, Rasmussen BB. Protein Supplementation Does Not Affect Myogenic Adaptations to Resistance Training. Med Sci Sports Exerc. 2017 Jun;49(6):1197-1208. doi: 10.1249/MSS.0000000000001224.
• Reidy PT, Borack MS, Markofski MM, Dickinson JM, Deer RR, Husaini SH, Walker DK, Igbinigie S, Robertson SM, Cope MB, Mukherjea R, Hall-Porter JM, Jennings K, Volpi E, Rasmussen BB. Protein Supplementation Has Minimal Effects on Muscle Adaptations during Resistance Exercise Training in Young Men: A Double-Blind Randomized Clinical Trial. J Nutr. 2016 Sep;146(9):1660-9. doi: 10.3945/jn.116.231803. Epub 2016 Jul 27.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: muscle; strength; protein; casein; soy; whey
• Other Study ID Numbers: CRC-D-179