Healthy
Conditions
Brief summary
The objective of this research project is to determine the impact on brain HEP metabolites and fluxes of an oral consumption of a commercially available nutrition product (Peptamen® 1.5 vanilla) in healthy volunteers. Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition product.
Interventions
Administration orally
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women aged between 18-45 years * Healthy, based on the medical screening visit * Normal BMI for age (18.5-25.0 kg/m2) * Able to understand and to sign a written informed consent prior to trial entry * Informed consent signed
Exclusion criteria
* Known type 1 or type 2 diabetes, on anamnesis * Family history of type 2 diabetes (parents) * Any other metabolic disease possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert) * Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc * Any history of neurological / psychological disease (meningitis, epilepsy), to the opinion of the investigator * Claustrophobia * Hearing disorders * Any medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert * Pregnancy (on anamnesis) and/or lactation * Having any metallic, electronic, magnetic, or mechanical implants, devices, or objects, for safety reason linked to magnetic field exposure (MRS): * Aneurysm clip(s) * Cardiac pacemaker * Implanted cardioverter defibrillator (ICD) * Electronic implant or device * Magnetically-activated implant or device * Neurostimulation system * Spinal cord stimulator * Cochlear implant or implanted hearing aid * Insulin or infusion pump * Implanted drug infusion device * Any type of prosthesis or implant * Artificial or prosthetic limb * Any metallic fragment or foreign body * Hearing aid * Other implant * Subject injured by a metallic object or foreign body * History of cancer within the past year * Allergy or intolerance to any food or compound used * Currently following a strict exercise program (minimum three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport * Currently participating or having participated in a clinical trial during the past month * Subjects not willing and/or not able to comply with scheduled visits and the requirements of the research protocol. Subject having a hierarchical link with the investigator or co-investigators. * Subject who cannot be expected to comply with the research protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 31P metabolites | 31P metabolites and fluxes will be measured during one hour 2 times, one before product intake (control) and the second one 45 min after product intake | The change in concentration of brain 31P metabolites |
Countries
Switzerland
Outcome results
None listed