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Completed

NCT Number: NCT04830514

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recommended Dietary Allowance of Protein

Other

0.8 g/kg/day protein intake

Other names: RDA

Habitual protein intake

Other

1.0 g/kg/day protein intake

Other names: NHANES

Optimal Protein Intake

Other

1.5 g/kg/day protein intake

Other names: OPI

Primary outcomes

  1. Whole Body Protein Turnover

    Time frame: 24 hour

    Isotope Tracer

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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