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NCT04612400 Clinical Trial

Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes

Healthy Clinical Trial

Official title:
Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04612400
Other study ID # 260813
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2020
Est. completion date September 6, 2021

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

Clinical Trial Summary

To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.

Description:

This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date September 6, 2021
Est. primary completion date September 6, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 40 Years
Eligibility Inclusion Criteria: - Aged 21-40 years. - Body weight of = 80kg. Exclusion Criteria: - History Chronic kidney disease. - History of dairy allergy or intolerance. - History of gastric reduction/bypass surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Oral amino acid tracer
Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.

Locations
Country Name City State
United States Center of Translational Research in Aging and Longevity 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 Net Balance grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations. 240 minutes
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