- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415973
Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly
January 17, 2012 updated by: University of Arkansas
This study will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins.
Study Overview
Status
Completed
Conditions
Detailed Description
STUDY OBJECTIVES Primary: To compare the effects of consumption of a 3-ounce serving of beef to that of a 20g serving of BPI on skeletal muscle synthetic and breakdown rate in healthy elderly subjects.
Secondary: To investigate the effect the study products on plasma levels of amino acids, insulin, and glucose in healthy elderly subjects.
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
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- UAMS Center on Aging
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female.
- Age 60 years or older.
Exclusion Criteria:
- Any (history of) gastrointestinal disease that interferes with GI function
- Diagnosed and active treatment of Diabetes Mellitus type I or II
- History of congestive heart failure
- Recent (6 months) hospitalization for heart disease treatment or management (e.g. PTCA, stent, surgery)
- Myocardial infarction in the past year
- Infection or fever in the 7 days prior to enrollment
- Current use of corticosteroids, growth hormone, or testosterone
- Adherence to a weight loss diet
- Use of protein-containing or amino acid-containing nutritional supplements within one week of enrollment
- Current alcohol (>7 ETOH per week) or drug abuse
- Platelet count (PLT) < 100,000
- History of hypo- or hyper-coagulation disorders including use of a coumadin derivative
- Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
- Allergy to local anesthetic
- Blood hemoglobin < 9.0 g/dL
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3 ounces of cooked, 85% lean ground beef
Subjects would consume 3 ounces of cooked, 85% lean ground beef at one setting on one day.
|
Consumed once per subject.
|
|
Experimental: 20 grams of Beef protein isolate
Subjects would consume 20 grams of beef protein isolate dissolved into 200mL water at one setting on one day.
|
Subjects would drink 200 ml water mixed with 20 grams of beef protein isolate one time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
skeletal muscle synthetic and breakdown rate
Time Frame: day one
|
Using stable isotope infusion/ingestion methodology, we will measure plasma and skeletal muscle metabolic rate.
Our primary end points will be muscle protein fractional synthesis rate (FSR) and whole body protein turnover rate.
|
day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concentrations of plasma amino acids, insulin and glucose
Time Frame: day one
|
Secondary endpoints are concentrations of plasma amino acids, insulin and glucose.
|
day one
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert R Wolfe, PhD, UAMS
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
July 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
August 10, 2011
First Submitted That Met QC Criteria
August 11, 2011
First Posted (Estimate)
August 12, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 17, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- UAMS IRB #132559
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
RAGE BioRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on 3 ounces of cooked, 85% lean ground beef
-
University of ArkansasCompletedProtein MetabolismUnited States