NCT01415973

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

August 10, 2011

Last Update Submit

January 17, 2012

Conditions

Keywords

beefproteinsynergyintact beef constituentsprotein constituentNutrient Synergy

Outcome Measures

Primary Outcomes (1)

  • skeletal muscle synthetic and breakdown rate

    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 Outcomes (1)

  • concentrations of plasma amino acids, insulin and glucose

    day one

Study Arms (2)

3 ounces of cooked, 85% lean ground beef

EXPERIMENTAL

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

20 grams of Beef protein isolate

EXPERIMENTAL

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

Interventions

Consumed once per subject.

3 ounces of cooked, 85% lean ground beef

Subjects would drink 200 ml water mixed with 20 grams of beef protein isolate one time.

20 grams of Beef protein isolate

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female.
  • Age 60 years or older.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAMS Center on Aging

Little Rock, Arkansas, 72205, United States

Location

Study Officials

  • Robert R Wolfe, PhD

    UAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 12, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations