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

Sponsor

University of Arkansas (Other)

Overall Status

Completed

CT.gov ID

NCT04612400

Collaborator

(none)

Enrollment

Location

Arms

10.1

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Oral amino acid tracer	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

double-blinded, randomized, crossover pilot studydouble-blinded, randomized, crossover pilot study

Masking:

Double (Participant, Investigator)

Masking Description:

This will be a double-blinded study. Both SP amounts are dissolved into equal volumes of water so that subjects will not know which amount they are ingesting. Blood samples are coded so that lab staff and investigators will not know which amount of SP was consumed at each visit. Investigators will be unblinded after all samples have been processed and data analysis has taken place.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 4, 2020

Actual Primary Completion Date :

Sep 6, 2021

Actual Study Completion Date :

Sep 6, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Whole-body protein net balance [240 minutes]
grams of protein per 240 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Translational Research in Aging and Longevity	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator: Arny A Ferrando, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT04612400

Other Study ID Numbers:

260813

First Posted:

Nov 3, 2020

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arkansas

Stable Isotopes

Validation

Whole-body protein metabolism

Study Results

No Results Posted as of Oct 20, 2021