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.
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Apr 2017
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2017
CompletedStudy Start
First participant enrolled
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2017
CompletedOctober 5, 2017
October 1, 2017
3 months
March 30, 2017
October 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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"
Study Arms (1)
nutrition product
OTHERPeptamen® 1.5 Vanilla, orally administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metabolic Unit, Clinical Development Unit, Nestec
Lausanne, 1000, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice Beaumont, MD
Société des Produits Nestlé (SPN)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2017
First Posted
April 5, 2017
Study Start
April 3, 2017
Primary Completion
July 7, 2017
Study Completion
July 21, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share