Phosphate Metabolites in Brain of Humans Aged 50+

Study Overview
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Brief Summary
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The objective of this research project is to determine in elderly subjects (>50 year old) by 31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and after consumption of 2 commercially available oral nutrition products

Official Title
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Assessment of Nutrition on Brain Energy Metabolism in Humans Aged 50+: Measurement of Phosphate Metabolites by 31P-MRS

Conditions
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Basic Science

Intervention / Treatment
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* Dietary Supplement: Peptamen® 1.5 Vanilla
* Dietary Supplement: Boost Plus® Vanilla


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 50 and 75 years Healthy, based on the medical screening visit Normal BMI for age (18.5-29.9 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, to the opinion of the medical expert Any ongoing medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert Any ongoing medication impacting the postprandial glucose and insulin response (like beta blockers), to the opinion of the medical expert Any ongoing medication impacting brain metabolism or function (neuroleptics, antidepressants, anti-epileptics), to the opinion of the medical expert Ongoing chemotherapy Any food supplement intake (e.g. MCT, ketone salts = Calcium, Sodium, Potassium, Magnesium) or special diet (e.g. ketogenic diet) possibly impacting basal ketone levels, to the opinion of the medical expert. Claustrophobia Hearing disorders (the participant placed into the MRS tunnel should be able to hear from the operators, for safety purpose) 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, like portacath® for instance 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 Allergy to cow milk or soy proteins Currently participating or having participated in an investigational 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peptamen® 1.5 Vanilla<br> | Dietary Supplement: Peptamen® 1.5 Vanilla<br>* Nutritionally complete formula with 10g MCT in 250 mL, commercially available<br>|
| Placebo Comparator: Boost Plus® Vanilla<br> | Dietary Supplement: Boost Plus® Vanilla<br>* Product of same nutritional composition but without MCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products |  | 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 |