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Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly

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ClinicalTrials.gov Identifier: NCT01415973
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins.

Condition or disease Intervention/treatment
Healthy Dietary Supplement: 3 ounces of cooked, 85% lean ground beef Dietary Supplement: 20 grams beef protein isolate

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly
Study Start Date : July 2011
Primary Completion Date : September 2011
Study Completion Date : January 2012
Arms and Interventions

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.
Dietary Supplement: 3 ounces of cooked, 85% lean ground beef
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.
Dietary Supplement: 20 grams beef protein isolate
Subjects would drink 200 ml water mixed with 20 grams of beef protein isolate one time.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. concentrations of plasma amino acids, insulin and glucose [ Time Frame: day one ]
    Secondary endpoints are concentrations of plasma amino acids, insulin and glucose.


Eligibility Criteria

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415973


Locations
United States, Arkansas
UAMS Center on Aging
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Robert R Wolfe, PhD UAMS
More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01415973     History of Changes
Other Study ID Numbers: UAMS IRB #132559
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by University of Arkansas:
beef
protein
synergy
intact beef constituents
protein constituent
Nutrient Synergy