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OpenTrials
Completed

NCT Number: NCT03541473

Phosphate Metabolites in Brain of Humans Aged 50+

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

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lausanne, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peptamen® 1.5 Vanilla

Dietary Supplement

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

Boost Plus® Vanilla

Dietary Supplement

Product of same nutritional composition but without MCT

Primary outcomes

  1. The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Ecole Polytechnique Fédérale de Lausanne

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 30, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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