Basic Science Clinical Trial
Official title:
Assessment of Nutrition on Brain Energy Metabolism in Humans Aged 50+: Measurement of Phosphate Metabolites by 31P-MRS
NCT number | NCT03541473 |
Other study ID # | 17.20.BIO |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 14, 2018 |
Est. completion date | October 19, 2018 |
Verified date | December 2018 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 25 |
Est. completion date | October 19, 2018 |
Est. primary completion date | October 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 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, 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 - 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | École Polytechnique Fédérale de Lausanne (EPFL) / Center for Biomedical Imaging (CIBM) | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Nestlé | Ecole Polytechnique Fédérale de Lausanne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products | 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" |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01860287 -
The Effects of Buprenorphine on Responses to Verbal Tasks
|
Early Phase 1 | |
Recruiting |
NCT05079516 -
Neural Basis of Sensory Learning: Brain Regions
|
N/A | |
Recruiting |
NCT05953038 -
LSD Occupancy of the Serotonin 2A Receptor in the Human Brain
|
Early Phase 1 | |
Recruiting |
NCT03289949 -
The Neurobiological Effect of 5-HT2AR Modulation
|
Phase 1 | |
Recruiting |
NCT05739994 -
Frontal and Parietal Contributions to Proprioception and Motor Skill Learning
|
N/A | |
Completed |
NCT04443647 -
Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli
|
N/A | |
Not yet recruiting |
NCT06411860 -
A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT05374460 -
Factors Affecting Sensory and Motor Learning
|
N/A | |
Recruiting |
NCT05124301 -
Neural Basis of Sensory and Motor Learning: Functional Connections
|
N/A |