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Phosphate Metabolites in Brain of Humans Aged 50+

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03541473
Enrollment
25
Registered
2018-05-30
Start date
2018-05-14
Completion date
2018-10-19
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basic Science

Brief summary

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

Interventions

DIETARY_SUPPLEMENTPeptamen® 1.5 Vanilla

Nutritionally complete formula with 10g MCT in 250 mL, commercially available

DIETARY_SUPPLEMENTBoost Plus® Vanilla

Product of same nutritional composition but without MCT

Sponsors

Ecole Polytechnique Fédérale de Lausanne
CollaboratorOTHER
Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products31P 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026