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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Oral amino acid tracer

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Center of Translational Research in Aging and Longevity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low; Low dose (6.3g) EAA/whey protein supplement	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.
Experimental: High; High dose (12.6g) EAA/whey protein supplement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Arny A Ferrando, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Validation; Stable Isotopes; Whole-body protein metabolism
• Other Study ID Numbers: 260813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No