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

Sponsor

DuPont Nutrition and Health (Industry)

Overall Status

Completed

CT.gov ID

NCT01749189

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle	Dietary Supplement: Blend Dietary Supplement: Whey Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Muscle Mass [Baseline, 6 weeks, 12 weeks]
Muscle Mass will be determined by DEXA

Secondary Outcome Measures

Change in Muscle Strength [Baseline, 6 weeks, 12 weeks]
Knee Extensor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Stable body weight, healthy, males aged 18-35

Exclusion Criteria:

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