High Energy Phosphate Metabolites in Brain

Assessment of Nutrition on Brain Energy Metabolism: Measurement of High Energy Phosphate Metabolites by 31-phosphorous Magnetic Resonance Spectroscopy.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Peptamen® 1.5 vanilla

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

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1000
    • Metabolic Unit, Clinical Development Unit, Nestec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: nutrition product; Peptamen® 1.5 Vanilla, orally administration	Other: Peptamen® 1.5 vanilla; Administration orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
31P metabolites	The change in concentration of brain 31P metabolites	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: Nestlé
• Collaborators: Ecole Polytechnique Fédérale de Lausanne
• Investigators: Principal Investigator: Maurice Beaumont, MD, Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 21, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16.19.CLI

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