Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement

To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Oral Nutrition Supplement

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)
• Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing
• Willing to provide signed informed consent

Exclusion Criteria:

• Smoker
• Patients with potential for non-compliance
• Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)
• Subject who in the Investigator's assessment cannot be expected to comply with study protocol
• Currently participating in another conflicting clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Impact Advanced Recovery; Oral nutrition supplement intended for consumption at 3 servings per day	Other: Oral Nutrition Supplement; Oral nutrition supplement intended for consumption at 3 servings per day
Experimental: Impact Advanced Recovery-R; Oral nutrition supplement intended for consumption at 3 servings per day	Other: Oral Nutrition Supplement; Oral nutrition supplement intended for consumption at 3 servings per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in plasma arginine levels in µmol/L	Pre-consumption, 30, 60, 120, 180, 240 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml	Pre-consumption, 30, 60, 120, 180, 240 minutes
Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml	Pre-consumption, 30, 60, 120, 180, 240 minutes

Other Outcome Measures

Outcome Measure	Time Frame
Change in plasma-free phospholipid Docosahexaenoic acid (DHA) in µg/ml	Pre-consumption, 30, 60, 120, 180, 240 minutes
Change in plasma phospholipid Docosahexaenoic acid (DHA) in µg/ml	Pre-consumption, 30, 60, 120, 180, 240 minutes

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Sherwyn Schwartz, MD, Diabetes & Glandular Disease Clinic, PA

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14.31.US.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO