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

NCT ID: NCT01749189

Last Updated: 2019-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo dry blended beverage (carbohydrate)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

22 grams of carbohydrate/day

Blend

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

Group Type EXPERIMENTAL

Blend

Intervention Type DIETARY_SUPPLEMENT

22 grams of protein/day

Whey

A dry blended beverage containing Whey protein

Group Type ACTIVE_COMPARATOR

Whey

Intervention Type DIETARY_SUPPLEMENT

22 grams of protein/day

Interventions

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Blend

22 grams of protein/day

Intervention Type DIETARY_SUPPLEMENT

Whey

22 grams of protein/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

22 grams of carbohydrate/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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DuPont Nutrition and Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blake Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Mark B Cope, PhD

Role: PRINCIPAL_INVESTIGATOR

Solae, LLC

Locations

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28346813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27466602 (View on PubMed)

Other Identifiers

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CRC-D-179

Identifier Type: -

Identifier Source: org_study_id

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