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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717234
• Other study ID #: 14.31.US.CLI
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Oral Nutrition Supplement
Oral nutrition supplement intended for consumption at 3 servings per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma-free phospholipid Docosahexaenoic acid (DHA) in µg/ml		Pre-consumption, 30, 60, 120, 180, 240 minutes
Other	Change in plasma phospholipid Docosahexaenoic acid (DHA) in µg/ml		Pre-consumption, 30, 60, 120, 180, 240 minutes
Primary	Change in plasma arginine levels in µmol/L		Pre-consumption, 30, 60, 120, 180, 240 minutes
Secondary	Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml		Pre-consumption, 30, 60, 120, 180, 240 minutes
Secondary	Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml		Pre-consumption, 30, 60, 120, 180, 240 minutes