Healthy
Conditions
Keywords
Medium Chain Triglycerides, Medium Chain Triglycerides metabolites, Peptamen 1.5
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
Interventions
DIETARY_SUPPLEMENTPeptamen 1.5
Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of plasma Medium Chain Triglycerides (MCT) | over 8 hours post intake | Tmax, Cmax and AUC for MCTs as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of plasma MCT metabolites such as free fatty acids | over 8 hours post intake | Tmax, Cmax and AUC for MCT metabolites as compared to baseline |
Countries
Switzerland
Outcome results
None listed