Back to resultsMaximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recommended Dietary Allowance of Protein
Habitual protein intake
Optimal Protein Intake
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring muscle loss, protein, animal-based protein
Eligibility Criteria
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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Recommended dietary allowance (RDA) for protein
Habitual protein intake consistent with population level norms
Optimal protein intake (OPI)
Arm Description
(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.
(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.
(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.
Outcomes
Primary Outcome Measures
Whole Body Protein Turnover
Isotope Tracer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830514
Brief Title
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Official Title
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
muscle loss, protein, animal-based protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recommended dietary allowance (RDA) for protein
Arm Type
Experimental
Arm Description
(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.
Arm Title
Habitual protein intake consistent with population level norms
Arm Type
Experimental
Arm Description
(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.
Arm Title
Optimal protein intake (OPI)
Arm Type
Experimental
Arm Description
(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.
Intervention Type
Other
Intervention Name(s)
Recommended Dietary Allowance of Protein
Other Intervention Name(s)
RDA
Intervention Description
0.8 g/kg/day protein intake
Intervention Type
Other
Intervention Name(s)
Habitual protein intake
Other Intervention Name(s)
NHANES
Intervention Description
1.0 g/kg/day protein intake
Intervention Type
Other
Intervention Name(s)
Optimal Protein Intake
Other Intervention Name(s)
OPI
Intervention Description
1.5 g/kg/day protein intake
Primary Outcome Measure Information:
Title
Whole Body Protein Turnover
Description
Isotope Tracer
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arny A Ferrando, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
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