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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Oral amino acid tracer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double-blinded, randomized, crossover pilot study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low<br>Low dose (6.3g) EAA/whey protein supplement | Other: Oral amino acid tracer<br>* 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.<br>|
| Experimental: High<br>High dose (12.6g) EAA/whey protein supplement | Other: Oral amino acid tracer<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable Isotopes, Validation, Whole-body protein metabolism