Clinical trial NCT03101345: High Energy Phosphate Metabolites in Brain
Official title: Assessment of Nutrition on Brain Energy Metabolism: Measurement of High Energy Phosphate Metabolites by 31-phosphorous Magnetic Resonance Spectroscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2017-04-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this research project is to determine the impact on brain HEP metabolites and fluxes of an oral consumption of a commercially available nutrition product (Peptamen® 1.5 vanilla) in healthy volunteers.

Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition product.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18-45 years
* Healthy, based on the medical screening visit
* Normal BMI for age (18.5-25.0 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
* Any history of neurological / psychological disease (meningitis, epilepsy), to the opinion of the investigator
* Claustrophobia
* Hearing disorders
* Any medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
* Pregnancy (on anamnesis) and/or lactation
* 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
  * 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
* History of cancer within the past year
* Allergy or intolerance to any food or compound used
* Currently following a strict exercise program (minimum three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport
* Currently participating or having participated in a clinical 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.
* Subject who cannot be expected to comply with the research protocol.

Primary outcomes:
measure: 31P metabolites
timeFrame: 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"
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic Unit, Clinical Development Unit, Nestec
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Maurice Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References: