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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Peptamen 1.5

• Registration Number: NCT02241681
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Study Start: 2014-10
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peptamen 1.5	Peptamen 1.5	500 mL of Peptamen 1.5

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Metabolic unit, clinical Development unit, Nestec; 🇨🇭 Lausanne, Switzerland