Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake

March 25, 2015 updated by: Société des Produits Nestlé (SPN)

Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details.

This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day.

Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1000
        • Metabolic Unit, Clinical Development Unit, Nestec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females
  • Aged between 20 and 65 years old
  • BMI in the normal range (18.5 to 25.0 kg/m2)
  • Having signed his/her consent form

Exclusion Criteria:

  • Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine)
  • Medically diagnosed anemia based on a blood formula
  • Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)
  • Smokers (anamnesis)
  • Pregnancy (anamnesis)
  • Under corticoids or hormone (adrenal, thyroid) treatment
  • Alcohol intake: > 2 units a day (anamnesis)
  • Consumption of illicit drugs (anamnesis)
  • Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
  • Subject who cannot be expected to comply with the study procedures, including consuming the test product
  • Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Peptamen 1.5
500 mL of Peptamen 1.5
Dietary supplement: Peptamen 1.5
Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of plasma Medium Chain Triglycerides (MCT)
Time Frame: over 8 hours post intake
Tmax, Cmax and AUC for MCTs as compared to baseline.
over 8 hours post intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of plasma MCT metabolites such as free fatty acids
Time Frame: over 8 hours post intake
Tmax, Cmax and AUC for MCT metabolites as compared to baseline
over 8 hours post intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Maurice Beaumont, MD,PhD, Metabolic Unit, Clinical Development Unit,Nestec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14.22.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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