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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04830514
Other study ID # 262424
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 27, 2021
Est. completion date March 15, 2022

Study information

Verified date October 2022
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Recommended Dietary Allowance of Protein
0.8 g/kg/day protein intake
Habitual protein intake
1.0 g/kg/day protein intake
Optimal Protein Intake
1.5 g/kg/day protein intake

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole Body Protein Turnover Isotope Tracer 24 hour
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