Role of Dietary Protein Intake in Elderly Adults

April 25, 2023 updated by: University of Arkansas

Role of Dietary Protein Intake on Whole Body Protein Balance in Elderly Adults

The investigators examined the effects of dietary protein intake in a mixed meal at two levels of protein amount on whole body protein metabolisms in older adults.

Study Overview

Detailed Description

The investigators determined the total anabolic response to an amount of protein intake commonly eaten with dinner (70g) as compared with the amount required to maximally stimulate muscle protein synthesis (35g). Men and women, ages > 60 years will be studied under two levels of protein intake in mixed meals in random order (35g or 70g protein in isocaloric mixed meals). For two days prior to each stable isotope tracer study, subjects' dietary intake of calories and protein will be stabilized by providing subjects their entire diets. On the third day, a 8-hr metabolic study will be conducted in the UAMS Reynolds Institute on Aging (IOA) to determine the total anabolic response to the particular amount of beef intake, which will be repeated with the other amount of protein in mixed meal after a minimum 7-day washout interval. The investigators measured whole body protein kinetics, muscle fractional synthetic rate, and plasma amino acid profile.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  • Men and women, ages > 60 years

Exclusion Criteria:

  • History of diabetes
  • History of malignancy in the 6 months prior to enrollment
  • History of gastrointestinal bypass surgery (Lapband, etc)
  • History of a chronic inflammatory condition or disease (Lupus, HIV/AIDS, etc)
  • Pregnant females
  • Subjects who do not or will not eat animal proteins
  • Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
  • Subjects who report regular resistance exercise (more than once per week)
  • Hemoglobin less than 9.5 mg/dL at the screening visit
  • Platelets less than 150,000 at the screening visit
  • Subjects who are not willing or able to suspend aspirin for several days prior to their muscle biopsies
  • Subjects who have been prescribed a blood-thinning medication (Coumadin, lovenox, heparin, Plavix, etc.)
  • Concomitant use of corticosteroids (ingestion, injection or transdermal)
  • Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

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: Recommended protein intake
Subjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat.
Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.
Experimental: Elevated protein intake
Subjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat.
Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in whole body anabolism
Time Frame: Change before and after a mixed meal intake for approximately 8 hours
Whole body net protein balance in gram protein
Change before and after a mixed meal intake for approximately 8 hours
Changes in skeletal muscle synthetic rate
Time Frame: Change before and after a mixed meal intake for approximately 8 hours
Skeletal muscle fractional synthetic rate in % synthesis
Change before and after a mixed meal intake for approximately 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Actual)

August 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 204291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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