Phosphate Metabolites in Brain of Humans Aged 50+

Basic Science Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541473
• Other study ID #: 17.20.BIO
• Status: Completed
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: December 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Basic Science

Intervention

Dietary Supplement:
• Peptamen® 1.5 Vanilla
Nutritionally complete formula with 10g MCT in 250 mL, commercially available
• Boost Plus® Vanilla
Product of same nutritional composition but without MCT

Locations

Country	Name	City	State
Switzerland	École Polytechnique Fédérale de Lausanne (EPFL) / Center for Biomedical Imaging (CIBM)	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"