High Energy Phosphate Metabolites in Brain

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Nutrition on Brain Energy Metabolism: Measurement of High Energy Phosphate Metabolites by 31-phosphorous Magnetic Resonance Spectroscopy.

Conditions
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Healthy

Intervention / Treatment
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* Other: Peptamen® 1.5 vanilla


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: nutrition product<br>Peptamen® 1.5 Vanilla, orally administration | Other: Peptamen® 1.5 vanilla<br>* Administration orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 31P metabolites | The change in concentration of brain 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 |