Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly

Sponsor

University of Arkansas (Other)

Overall Status

Completed

CT.gov ID

NCT01415973

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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	Phase
Healthy	Dietary Supplement: 3 ounces of cooked, 85% lean ground beef Dietary Supplement: 20 grams beef protein isolate	N/A

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

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 :

Jul 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Jan 1, 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.

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

skeletal muscle synthetic and breakdown rate [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

concentrations of plasma amino acids, insulin and glucose [day one]
Secondary endpoints are concentrations of plasma amino acids, insulin and glucose.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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