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OpenTrials
Completed

NCT Number: NCT01749189

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.

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Key information

Conditions

Muscle

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blend

Dietary Supplement

22 grams of protein/day

Whey

Dietary Supplement

22 grams of protein/day

Placebo

Dietary Supplement

22 grams of carbohydrate/day

Primary outcomes

  1. Change in Muscle Mass

    Time frame: Baseline, 6 weeks, 12 weeks

    Muscle Mass will be determined by DEXA

Secondary outcomes

  1. Change in Muscle Strength

    Time frame: Baseline, 6 weeks, 12 weeks

    Knee Extensor

Sponsors and collaborators

Lead sponsor

DuPont Nutrition and Health

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2012
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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