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Completed

NCT Number: NCT03765710

Role of Dietary Protein Intake 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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Recommended protein intake

Other

Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.

Elevated protein intake

Other

Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2018
Registry last updated
Apr 26, 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.