High Energy Phosphate Metabolites in Brain

NCT ID: NCT03101345

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2017-07-21

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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nutrition product

Peptamen® 1.5 Vanilla, orally administration

Group Type OTHER

Peptamen® 1.5 vanilla

Intervention Type OTHER

Administration orally

Interventions

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Peptamen® 1.5 vanilla

Administration orally

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Beaumont, MD

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé (SPN)

Locations

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Metabolic Unit, Clinical Development Unit, Nestec

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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16.19.CLI

Identifier Type: -

Identifier Source: org_study_id