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

Muscle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749189
• Other study ID #: CRC-D-179
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2019
• Source: DuPont Nutrition and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Muscle

Intervention

Dietary Supplement:
• Blend
22 grams of protein/day
• Whey
22 grams of protein/day
• Placebo
22 grams of carbohydrate/day

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
DuPont Nutrition and Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle Mass	Muscle Mass will be determined by DEXA	Baseline, 6 weeks, 12 weeks
Secondary	Change in Muscle Strength	Knee Extensor	Baseline, 6 weeks, 12 weeks