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Completed

NCT Number: NCT02241681

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

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.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic unit, clinical Development unit, Nestec

Lausanne, 1000, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peptamen 1.5

Dietary Supplement

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

Primary outcomes

  1. Measure of plasma Medium Chain Triglycerides (MCT)

    Time frame: over 8 hours post intake

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

Secondary outcomes

  1. Measure of plasma MCT metabolites such as free fatty acids

    Time frame: over 8 hours post intake

    Tmax, Cmax and AUC for MCT metabolites as compared to baseline

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 16, 2014
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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