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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717234
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Other: Oral Nutrition Supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in plasma arginine levels in µmol/L [ Time Frame: Pre-consumption, 30, 60, 120, 180, 240 minutes ]

Secondary Outcome Measures :
  1. Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml [ Time Frame: Pre-consumption, 30, 60, 120, 180, 240 minutes ]
  2. Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml [ Time Frame: Pre-consumption, 30, 60, 120, 180, 240 minutes ]

Other Outcome Measures:
  1. Change in plasma-free phospholipid Docosahexaenoic acid (DHA) in µg/ml [ Time Frame: Pre-consumption, 30, 60, 120, 180, 240 minutes ]
  2. Change in plasma phospholipid Docosahexaenoic acid (DHA) in µg/ml [ Time Frame: Pre-consumption, 30, 60, 120, 180, 240 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717234


Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Sherwyn Schwartz, MD Diabetes & Glandular Disease Clinic, PA
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02717234    
Other Study ID Numbers: 14.31.US.CLI
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No