Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01415973
First received: August 10, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • skeletal muscle synthetic and breakdown rate [ Time Frame: day one ] [ Designated as safety issue: No ]
    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:
  • concentrations of plasma amino acids, insulin and glucose [ Time Frame: day one ] [ Designated as safety issue: No ]
    Secondary endpoints are concentrations of plasma amino acids, insulin and glucose.


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01415973     History of Changes
Other Study ID Numbers: UAMS IRB #132559
Study First Received: August 10, 2011
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014