- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03765710
Role of Dietary Protein Intake in Elderly Adults
April 25, 2023 updated by: University of Arkansas
Role of Dietary Protein Intake on Whole Body Protein Balance 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recommended protein intake
Subjects consumed a mixed meal with a macronutrient distribution of 13% protein, 54% carbohydrate, and 33% fat.
|
Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.
|
Experimental: Elevated protein intake
Subjects consumed a mixed meal with a macronutrient distribution of 26% protein, 44% carbohydrate, and 30% fat.
|
Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change before and after a mixed meal intake for approximately 8 hours
|
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
|
Change before and after a mixed meal intake for approximately 8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
November 26, 2018
First Submitted That Met QC Criteria
December 3, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
April 26, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 204291
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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