High Energy Phosphate Metabolites in Brain

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Peptamen® 1.5 vanilla

• Registration Number: NCT03101345
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study Start: 2017-04-03
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-05
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nutrition product	Peptamen® 1.5 vanilla	Peptamen® 1.5 Vanilla, orally administration

Primary Outcome Measures

Name	Time	Method
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"	The change in concentration of brain 31P metabolites

Trial Locations

Locations (1)

Metabolic Unit, Clinical Development Unit, Nestec; 🇨🇭 Lausanne, Switzerland