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CompletedNCT01749189Updated Oct 7, 2019

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

An interventional study of Blend and Whey in Muscle, sponsored by DuPont Nutrition and Health. Completed at 1 site in United States. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-07.

Sponsored by DuPont Nutrition and Health · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Muscle

Keywords

  • soy
  • whey
  • casein
  • muscle
  • strength
  • protein
03

In context

Lead sponsor

DuPont Nutrition and Health is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo dry blended beverage (carbohydrate)

    Dietary Supplement: Placebo

  • Experimental
    Blend

    A dry blended beverage containing a protein blend of soy, whey and casein

    Dietary Supplement: Blend

  • Active comparator
    Whey

    A dry blended beverage containing Whey protein

    Dietary Supplement: Whey

Interventions

  • Dietary supplementBlend

    22 grams of protein/day

  • Dietary supplementWhey

    22 grams of protein/day

  • Dietary supplementPlacebo

    22 grams of carbohydrate/day

06

What researchers measure

Primary outcomes

  1. Change in Muscle Mass

    Muscle Mass will be determined by DEXA

    Time frame: Baseline, 6 weeks, 12 weeks

Secondary outcomes

  1. Change in Muscle Strength

    Knee Extensor

    Time frame: Baseline, 6 weeks, 12 weeks

07

Study locations

1 site
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
08

References and documents

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. PubMed 28346813 ↗
  • 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. PubMed 27466602 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01749189
Lead sponsor
DuPont Nutrition and Health
Responsible party
Sponsor
First posted
Dec 13, 2012
Start date
Jul 2012
Primary completion
May 2014
Completion
Jun 2014
Last update
Oct 7, 2019

Study contacts

Blake Rasmussen, PhD
principal investigator · University of Texas
Mark B Cope, PhD
principal investigator · Solae, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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