High Energy Phosphate Metabolites in Brain

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Unit, Clinical Development Unit, Nestec

Lausanne, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peptamen® 1.5 vanilla

Other

Administration orally

Primary outcomes

31P metabolites

Time frame: 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

Ecole Polytechnique Fédérale de Lausanne

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Apr 5, 2017
Registry last updated: Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed