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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241681
• Other study ID #: 14.22.MET
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: March 25, 2015
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Peptamen 1.5
Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.

Locations

Country	Name	City	State
Switzerland	Metabolic unit, clinical Development unit, Nestec	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of plasma Medium Chain Triglycerides (MCT)	Tmax, Cmax and AUC for MCTs as compared to baseline.	over 8 hours post intake	No
Secondary	Measure of plasma MCT metabolites such as free fatty acids	Tmax, Cmax and AUC for MCT metabolites as compared to baseline	over 8 hours post intake	No