NCT04830514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

March 31, 2021

Results QC Date

October 5, 2022

Last Update Submit

October 5, 2022

Conditions

Sarcopenia

Keywords

muscle lossproteinanimal-based protein

Outcome Measures

Primary Outcomes (1)

  • Whole Body Protein Turnover

    Isotope Tracer

    24 hour

Study Arms (3)

Recommended dietary allowance (RDA) for protein

EXPERIMENTAL

(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

Habitual protein intake consistent with population level norms

EXPERIMENTAL

(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

Optimal protein intake (OPI)

EXPERIMENTAL

(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

Interventions

Recommended Dietary Allowance of ProteinOTHER

0.8 g/kg/day protein intake

Also known as: RDA
Recommended dietary allowance (RDA) for protein
Habitual protein intakeOTHER

1.0 g/kg/day protein intake

Also known as: NHANES
Habitual protein intake consistent with population level norms
Optimal Protein IntakeOTHER

1.5 g/kg/day protein intake

Also known as: OPI
Optimal protein intake (OPI)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • Church DD, Hirsch KR, Kviatkovsky SA, Matthews JJ, Henderson RA, Azhar G, Wolfe RR, Ferrando AA. Effect of 3 Different Daily Protein Intakes in a 2-Meal Eating Pattern on Protein Turnover in Middle Age and Older Adults: A Randomized Controlled Trial. J Nutr. 2025 May;155(5):1364-1372. doi: 10.1016/j.tjnut.2024.12.025. Epub 2024 Dec 28.

    PMID: 39736329DERIVED

MeSH Terms

Conditions

SarcopeniaMuscular Atrophy

Interventions

Nutrition Surveys

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
David D. Church, Ph.D., Assistant Professor
Organization
University of Arkansas for Medical Sciences
dchurch@uams.edu
5015265709

Study Officials

  • Arny A Ferrando, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

May 27, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

August 24, 2023

Results First Posted

August 24, 2023

Record last verified: 2022-10

Locations

US(1)