HealthyNCT03101345
High Energy Phosphate Metabolites in Brain
A study testing Peptamen® 1.5 vanilla in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Peptamen® 1.5 vanilla
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Apr 2017to 21 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Metabolic Unit, Clinical Development Unit, Nestec
Lausanne, 1000
About this study
Official title: Assessment of Nutrition on Brain Energy Metabolism: Measurement of High Energy Phosphate Metabolites by 31-phosphorous Magnetic Resonance Spectroscopy.
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.
- Conditions
- Healthy
- Being tested
- Peptamen® 1.5 vanilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen® 1.5 vanillaOther
Administration orally
| Study group | Role | What they receive |
|---|---|---|
| nutrition product | Other | Peptamen® 1.5 Vanilla, orally administration Receives: Other: Peptamen® 1.5 vanilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
31P metabolites
The change in concentration of brain 31P metabolites
Measured: 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"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start3 Apr 2017
- Primary completion7 Jul 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, Principal investigator, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101345
- Sponsor's protocol ID
- 16.19.CLI
- Status last verified
- Oct 2017
- First submitted
- 30 Mar 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutrition on Brain Energy Metabolism: Measurement of High Energy Phosphate Metabolites by 31-phosphorous Magnetic Resonance Spectroscopy.
- ClinicalTrials.gov ID
- NCT03101345
- Acronym / sponsor ID
- 16.19.CLI
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nutrition product | Other | Other: Peptamen® 1.5 vanillaPeptamen® 1.5 Vanilla, orally administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptamen® 1.5 vanillaAdministration orally | Other | nutrition product |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Beaumont, MD principal investigator
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen® 1.5 vanilla in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.