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

Société des Produits Nestlé (SPN)20 enrolled

Overview

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.

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

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Peptamen 1.5DIETARY_SUPPLEMENT

Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Metabolic unit, clinical Development unit, Nestec

Lausanne, Switzerland

Outcomes

Primary Outcomes

Measure of plasma Medium Chain Triglycerides (MCT)

Tmax, Cmax and AUC for MCTs as compared to baseline.

Time frame: over 8 hours post intake

Secondary Outcomes

Measure of plasma MCT metabolites such as free fatty acids

Tmax, Cmax and AUC for MCT metabolites as compared to baseline

Time frame: over 8 hours post intake

Data from ClinicalTrials.gov

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