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CompletedNCT02241681Updated Mar 26, 2015

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

An interventional study of Peptamen 1.5 in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Healthy

Keywords

  • Medium Chain Triglycerides
  • Medium Chain Triglycerides metabolites
  • Peptamen 1.5
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Peptamen 1.5

    500 mL of Peptamen 1.5

    Dietary Supplement: Peptamen 1.5

Interventions

  • Dietary supplementPeptamen 1.5

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Metabolic unit, clinical Development unit, Nestec
    Lausanne, 1000, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02241681
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Sep 16, 2014
Start date
Oct 2014
Primary completion
Nov 2014
Completion
Jan 2015
Last update
Mar 26, 2015

Study contacts

Maurice Beaumont, MD,PhD
principal investigator · Metabolic Unit, Clinical Development Unit,Nestec

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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