Phosphate Metabolites in Brain of Humans Aged 50+

NCT03541473 | Completed

• 1 other identifier: 17.20.BIO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Basic Science

Outcome Measures

Primary Outcomes (1)

• 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"

Study Arms (2)

Peptamen® 1.5 Vanilla

ACTIVE COMPARATOR

Dietary Supplement: Peptamen® 1.5 Vanilla

Boost Plus® Vanilla

PLACEBO COMPARATOR

Dietary Supplement: Boost Plus® Vanilla

Interventions

Peptamen® 1.5 Vanilla DIETARY_SUPPLEMENT

Nutritionally complete formula with 10g MCT in 250 mL, commercially available

Peptamen® 1.5 Vanilla

Boost Plus® Vanilla DIETARY_SUPPLEMENT

Product of same nutritional composition but without MCT

Boost Plus® Vanilla

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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, 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)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

École Polytechnique Fédérale de Lausanne (EPFL) / Center for Biomedical Imaging (CIBM)

Lausanne, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: May 14, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)