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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01749189
Enrollment
58
Registered
2012-12-13
Start date
2012-07-31
Completion date
2014-06-30
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle

Keywords

soy, whey, casein, muscle, strength, protein

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.

Interventions

DIETARY_SUPPLEMENTBlend

22 grams of protein/day

DIETARY_SUPPLEMENTWhey

22 grams of protein/day

DIETARY_SUPPLEMENTPlacebo

22 grams of carbohydrate/day

Sponsors

DuPont Nutrition and Health
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Muscle MassBaseline, 6 weeks, 12 weeksMuscle Mass will be determined by DEXA

Secondary

MeasureTime frameDescription
Change in Muscle StrengthBaseline, 6 weeks, 12 weeksKnee Extensor

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026