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CompletedNCT03101345Updated Oct 5, 2017

High Energy Phosphate Metabolites in Brain

An interventional study of Peptamen® 1.5 vanilla in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-05.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    nutrition product

    Peptamen® 1.5 Vanilla, orally administration

    Other: Peptamen® 1.5 vanilla

Interventions

  • OtherPeptamen® 1.5 vanilla

    Administration orally

06

What researchers measure

Primary outcomes

  1. 31P metabolites

    The change in concentration of brain 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"

07

Study locations

1 site
  • Metabolic Unit, Clinical Development Unit, Nestec
    Lausanne, 1000, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03101345
Lead sponsor
Société des Produits Nestlé (SPN)
Collaborators
Ecole Polytechnique Fédérale de Lausanne
Responsible party
Sponsor
First posted
Apr 5, 2017
Start date
Apr 3, 2017
Primary completion
Jul 7, 2017
Completion
Jul 21, 2017
Last update
Oct 5, 2017

Study contacts

Maurice Beaumont, MD
principal investigator · Société des Produits Nestlé (SPN)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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