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

NCT04612400 | Completed Results

• 1 other identifier: 260813
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Stable Isotopes; Validation; Whole-body protein metabolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low

EXPERIMENTAL

Low dose (6.3g) EAA/whey protein supplement

Other: Oral amino acid tracer

High

EXPERIMENTAL

High dose (12.6g) EAA/whey protein supplement

Other: Oral amino acid tracer

Interventions

Oral amino acid tracer OTHER

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.

High; Low

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 21-40 years.
• Body weight of ≤ 80kg.

You may not qualify if:

• History Chronic kidney disease.
• History of dairy allergy or intolerance.
• History of gastric reduction/bypass surgery.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Center of Translational Research in Aging and Longevity

Little Rock, Arkansas, 72205, United States

Location

Results Point of Contact

• Title: Katie Rose Hisrch, Ph.D.
• Organization: The University of Arkansas for Medical Sciences

krhirsch@uams.edu

5015265708

Study Officials

• Arny A Ferrando, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blinded, randomized, crossover pilot study

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: November 4, 2020
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: August 28, 2023
• Results First Posted: August 28, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)