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

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Other: Recommended Dietary Allowance of Protein; Other: Habitual protein intake; Other: Optimal Protein Intake

• Registration Number: NCT04830514
• Lead Sponsor: University of Arkansas

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Study Start: 2021-05-27
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-10
• Results First Submitted: 2022-10-05
• Results First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Results First Posted: 2023-08-24
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recommended dietary allowance (RDA) for protein	Recommended Dietary Allowance of 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.
Habitual protein intake consistent with population level norms	Habitual protein intake	(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.
Optimal protein intake (OPI)	Optimal Protein Intake	(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.

Primary Outcome Measures

Name	Time	Method
Whole Body Protein Turnover	24 hour	Isotope Tracer

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States