Basic ScienceNCT03541473
Phosphate Metabolites in Brain of Humans Aged 50+
A study testing Peptamen® 1.5 Vanilla and Boost Plus® Vanilla in people with Basic Science, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The objective of this research project is to determine in elderly subjects (>50 year old) by 31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and after consumption of 2 commercially available oral nutrition products Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science
- What is being tested?
- Peptamen® 1.5 Vanilla and Boost Plus® Vanilla
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 May 2018to 19 Oct 2018
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 50 and 75 years
- Healthy, based on the medical screening visit
- Normal BMI for age (18.5-29.9 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, to the opinion of the medical expert
- Any ongoing medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
- Any ongoing medication impacting the postprandial glucose and insulin response (like beta blockers), to the opinion of the medical expert
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- Any ongoing medication impacting brain metabolism or function (neuroleptics, antidepressants, anti-epileptics), to the opinion of the medical expert
- Ongoing chemotherapy
- Any food supplement intake (e.g. MCT, ketone salts = Calcium, Sodium, Potassium, Magnesium) or special diet (e.g. ketogenic diet) possibly impacting basal ketone levels, to the opinion of the medical expert.
- Claustrophobia
- Hearing disorders (the participant placed into the MRS tunnel should be able to hear from the operators, for safety purpose)
- 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, like portacath® for instance
- 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
- Allergy to cow milk or soy proteins
- Currently participating or having participated in an investigational 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
École Polytechnique Fédérale de Lausanne (EPFL) / Center for Biomedical Imaging (CIBM)
Lausanne
About this study
Official title: Assessment of Nutrition on Brain Energy Metabolism in Humans Aged 50+: Measurement of Phosphate Metabolites by 31P-MRS
The objective of this research project is to determine in elderly subjects (>50 year old) by 31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and after consumption of 2 commercially available oral nutrition products
- Conditions
- Basic Science
- Being tested
- Peptamen® 1.5 Vanilla, Boost Plus® Vanilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen® 1.5 VanillaDietary supplement
Nutritionally complete formula with 10g MCT in 250 mL, commercially available
Boost Plus® VanillaDietary supplement
Product of same nutritional composition but without MCT
| Study group | Role | What they receive |
|---|---|---|
| Peptamen® 1.5 Vanilla | Active comparator | Not described Receives: Dietary Supplement: Peptamen® 1.5 Vanilla |
| Boost Plus® Vanilla | Placebo comparator | Not described Receives: Dietary Supplement: Boost Plus® Vanilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products
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 posted30 May 2018
- Study start14 May 2018
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic ScienceStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541473
- Sponsor's protocol ID
- 17.20.BIO
- Status last verified
- Dec 2018
- First submitted
- 17 May 2018
- Last updated
- 5 Dec 2018
- 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 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutrition on Brain Energy Metabolism in Humans Aged 50+: Measurement of Phosphate Metabolites by 31P-MRS
- ClinicalTrials.gov ID
- NCT03541473
- Acronym / sponsor ID
- 17.20.BIO
- Conditions
- Basic Science
- 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
- 14 May 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 30 May 2018 (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 in elderly subjects (>50 year old) by 31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and after consumption of 2 commercially available oral nutrition products
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peptamen® 1.5 Vanilla | Active comparator | Dietary Supplement: Peptamen® 1.5 Vanilla |
| Boost Plus® Vanilla | Placebo comparator | Dietary Supplement: Boost Plus® Vanilla |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 50 and 75 years
- Healthy, based on the medical screening visit
- Normal BMI for age (18.5-29.9 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, to the opinion of the medical expert
- Any ongoing medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
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 VanillaNutritionally complete formula with 10g MCT in 250 mL, commercially available | Dietary supplement | Peptamen® 1.5 Vanilla |
| Boost Plus® VanillaProduct of same nutritional composition but without MCT | Dietary supplement | Boost Plus® Vanilla |
Primary outcome
The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products
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"
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 Dec 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Boost Plus® Vanilla in people with Basic Science, 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 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products (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 Dec 2018.