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

NCT02241681 | Completed

• 1 other identifier: 14.22.MET
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Medium Chain Triglycerides; Medium Chain Triglycerides metabolites; Peptamen 1.5

Outcome Measures

Primary Outcomes (1)

• Measure of plasma Medium Chain Triglycerides (MCT)

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

  over 8 hours post intake

Secondary Outcomes (1)

• Measure of plasma MCT metabolites such as free fatty acids

  over 8 hours post intake

Study Arms (1)

Peptamen 1.5

OTHER

500 mL of Peptamen 1.5

Dietary Supplement: Peptamen 1.5

Interventions

Peptamen 1.5 DIETARY_SUPPLEMENT

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

Peptamen 1.5

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Metabolic unit, clinical Development unit, Nestec

Lausanne, 1000, Switzerland

Location

Study Officials

• Maurice Beaumont, MD,PhD

  Metabolic Unit, Clinical Development Unit,Nestec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 26, 2015

Record last verified: 2014-11

Locations

CH (1)