MuscleNCT01749189
Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
A study testing Blend and Whey in people with Muscle, run by DuPont Nutrition and Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle
- What is being tested?
- Blend and Whey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stable body weight, healthy, males aged 18-35
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: A Randomized, Controlled Double Blind Longitudinal Study: 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.
- Conditions
- Muscle
- Being tested
- Blend, Whey, Placebo
- Keywords
- soy, whey, casein, muscle, strength, protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlendDietary supplement
22 grams of protein/day
WheyDietary supplement
22 grams of protein/day
PlaceboDietary supplement
22 grams of carbohydrate/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo dry blended beverage (carbohydrate) Receives: Dietary Supplement: Placebo |
| Blend | Experimental | A dry blended beverage containing a protein blend of soy, whey and casein Receives: Dietary Supplement: Blend |
| Whey | Active comparator | A dry blended beverage containing Whey protein Receives: Dietary Supplement: Whey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Mass
Muscle Mass will be determined by DEXA
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (1)
Change in Muscle Strength
Knee Extensor
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- DuPont Nutrition and Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Blake Rasmussen, PhD, Principal investigator, University of TexasMark B Cope, PhD, Principal investigator, Solae, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749189
- Sponsor's protocol ID
- CRC-D-179
- Status last verified
- Oct 2019
- First submitted
- 15 Nov 2012
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Von Ruff ZD, Miller MJ, Moro T, Reidy PT, Ebert SM, Volpi E, Adams CM, Rasmussen BB. Resistance exercise training in older men reduces ATF4-activated and senescence-associated mRNAs in skeletal muscle. Geroscience. 2025 Jun;47(3):4601-4622. doi: 10.1007/s11357-025-01564-2. Epub 2025 Feb 27.
PubMed 40011348Reidy 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 28346813Reidy 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Double Blind Longitudinal Study: Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
- ClinicalTrials.gov ID
- NCT01749189
- Acronym / sponsor ID
- CRC-D-179
- Conditions
- Muscle
- Keywords
- soy, whey, casein, muscle, strength, protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- DuPont Nutrition and HealthIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo dry blended beverage (carbohydrate) |
| Blend | Experimental | Dietary Supplement: BlendA dry blended beverage containing a protein blend of soy, whey and casein |
| Whey | Active comparator | Dietary Supplement: WheyA dry blended beverage containing Whey protein |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Stable body weight, healthy, males aged 18-35
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blend22 grams of protein/day | Dietary supplement | Blend |
| Whey22 grams of protein/day | Dietary supplement | Whey |
| Placebo22 grams of carbohydrate/day | Dietary supplement | Placebo |
Primary outcome
Change in Muscle Mass
Time frame: Baseline, 6 weeks, 12 weeks
Muscle Mass will be determined by DEXA
1 secondary outcome
Change in Muscle Strength
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Derived from this study: PubMed 40011348Von Ruff ZD, Miller MJ, Moro T, Reidy PT, Ebert SM, Volpi E, Adams CM, Rasmussen BB. Resistance exercise training in older men reduces ATF4-activated and senescence-associated mRNAs in skeletal muscle. Geroscience. 2025 Jun;47(3):4601-4622. doi: 10.1007/s11357-025-01564-2. Epub 2025 Feb 27.
- Derived from this study: PubMed 28346813Reidy 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.
- Derived from this study: PubMed 27466602Reidy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blake Rasmussen, PhD principal investigator
University of Texas
Mark B Cope, PhD principal investigator
Solae, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blend and Whey in people with Muscle, run by DuPont Nutrition and Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Mass (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01749189, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.