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

NCT ID: NCT02241681

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-01-31

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Peptamen 1.5

500 mL of Peptamen 1.5

Group Type: OTHER

Peptamen 1.5

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Peptamen 1.5

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurice Beaumont, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Metabolic Unit, Clinical Development Unit,Nestec

Locations

Metabolic unit, clinical Development unit, Nestec

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

14.22.MET

Identifier Type: -

Identifier Source: org_study_id