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

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

Study Overview

• Status: Completed
• Conditions: Basic Science
• Intervention / Treatment: Dietary supplement: Peptamen® 1.5 Vanilla; Dietary supplement: Boost Plus® Vanilla

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • École Polytechnique Fédérale de Lausanne (EPFL) / Center for Biomedical Imaging (CIBM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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"

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Ecole Polytechnique Fédérale de Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): October 19, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17.20.BIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No