High Energy Phosphate Metabolites in Brain

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101345
• Other study ID #: 16.19.CLI
• Status: Completed
• Phase: N/A
• First received: March 30, 2017
• Last updated: October 4, 2017
• Start date: April 3, 2017
• Est. completion date: July 21, 2017

Study information

• Verified date: October 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 21, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Peptamen® 1.5 vanilla
Administration orally

Locations

Country	Name	City	State
Switzerland	Metabolic Unit, Clinical Development Unit, Nestec	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	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"