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

NCT ID: NCT04830514

Last Updated: 2023-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-03-15

Brief Summary

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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

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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.

Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Recommended Dietary Allowance of Protein

Intervention Type OTHER

0.8 g/kg/day protein intake

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.

Group Type EXPERIMENTAL

Habitual protein intake

Intervention Type OTHER

1.0 g/kg/day protein intake

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.

Group Type EXPERIMENTAL

Optimal Protein Intake

Intervention Type OTHER

1.5 g/kg/day protein intake

Interventions

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Recommended Dietary Allowance of Protein

0.8 g/kg/day protein intake

Intervention Type OTHER

Habitual protein intake

1.0 g/kg/day protein intake

Intervention Type OTHER

Optimal Protein Intake

1.5 g/kg/day protein intake

Intervention Type OTHER

Other Intervention Names

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RDA NHANES OPI

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arny A Ferrando, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39736329 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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262424

Identifier Type: -

Identifier Source: org_study_id

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