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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Oral amino acid tracer

• Registration Number: NCT04612400
• Lead Sponsor: University of Arkansas

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-03
• Study Start: 2020-11-04
• Primary Completion: 2021-09-06
• Study Completion: 2021-09-06
• Results First Submitted: 2022-04-12
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Results First Posted: 2023-08-28
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High	Oral amino acid tracer	High dose (12.6g) EAA/whey protein supplement
Low	Oral amino acid tracer	Low dose (6.3g) EAA/whey protein supplement

Primary Outcome Measures

Name	Time	Method
Whole-body Protein Net Balance	240 minutes	grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations.

Trial Locations

Locations (1)

Center of Translational Research in Aging and Longevity; 🇺🇸 Little Rock, Arkansas, United States