- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847261
Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults
October 3, 2019 updated by: DuPont Nutrition and Health
A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown in Healthy Older Adults
During aging there is a tendency for muscle protein synthesis (growth) to become less efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can affect strength and mobility.
Protein consumption may be one opportunity to alleviate this problem especially when consumed in appropriate amounts following resistance training.
This study is designed to determine if a soy dairy protein blend, shown to be effective in younger adults, will produce beneficial muscle protein synthesis in older healthy adults following resistance exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- University of Texas Medical Branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
55-70 yr olds Stable Body weight
Exclusion Criteria:
- Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- Significant heart, liver, kidney, blood, respiratory disease or thyroid issues
- Peripheral vascular disease
- Orthopedic injury that prohibits participation in the exercise training
- Diabetes mellitus or other untreated endocrine disease
- Active cancer (all groups) and history of cancer
- Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
- Neurologic Injury or disease
- Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
- Alcohol or drug abuse
- Tobacco use (smoking or chewing)
- Malnutrition (BMI < 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
- Obesity (BMI > 30 kg/m2)
- Low hemoglobin levels (below normal values)
- Food allergies
- Taking dietary supplements such as green tea, omega 3 fatty acids, etc.
- Females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Soy Dairy Protein Blend
30 grams of Soy Dairy Protein Blend given as a single beverage following leg resistance exercise
|
|
|
Active Comparator: Positive Control (Dairy Whey Protein)
30 grams of Dairy Whey Protein will be given as a single beverage following leg resistance exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional Synthetic Rate (Muscle Protein Synthesis)
Time Frame: baseline, 3 hrs, 5 hrs
|
The fractional synthesis rate (FSR) of mixed muscle proteins will be calculated from the incorporation rate of L-[ring-13C6]Phenylalanine into the mixed muscle proteins, and the free-tissue phenylalanine enrichment.
|
baseline, 3 hrs, 5 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anti-inflammatory and Anti-oxidant Markers
Time Frame: baseline, 3 hrs, 5 hrs
|
Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx).
|
baseline, 3 hrs, 5 hrs
|
|
Intracellular Signalling Genes and Proteins
Time Frame: baseline, 3 hrs, 5 hrs
|
Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques
|
baseline, 3 hrs, 5 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Blake Rasmussen, PhD, University of Texas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
April 24, 2013
First Submitted That Met QC Criteria
May 1, 2013
First Posted (Estimate)
May 6, 2013
Study Record Updates
Last Update Posted (Actual)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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