Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics

October 5, 2022 updated by: University of Arkansas
A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.

3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI ≤ 35 kg/m2
  • Capable of providing informed consent
  • COVID-19 negative and/or asymptomatic

Exclusion Criteria:

  • Subject who does not/will not eat animal protein sources.
  • Body mass index > 35.
  • History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
  • Use of insulin to control blood sugar level.
  • Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
  • Currently using prescription blood thinning medications.
  • Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
  • Unwilling to avoid using protein or amino-acid supplements during participation.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recommended dietary allowance (RDA) for protein
(RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Other: Recommended Dietary Allowance of Protein
0.8 g/kg/day protein intake
Other Names:
  • RDA
Experimental: Habitual protein intake consistent with population level norms
(NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Other: Habitual protein intake
1.0 g/kg/day protein intake
Other Names:
  • NHANES
Experimental: Optimal protein intake (OPI)
(OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks.
Other: Optimal Protein Intake
1.5 g/kg/day protein intake
Other Names:
  • OPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Body Protein Turnover
Time Frame: 24 hour
Isotope Tracer
24 hour

Collaborators and Investigators

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

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Arny A Ferrando, PhD, University of Arkansas

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)

May 27, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262424

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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