COGNIKET-MCI Trial: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-country, Pivotal Trial to Study the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides (kMCT) and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment
Société des Produits Nestlé (SPN)
Summary
Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Have read, understood, and signed the informed consent form (ICF). 2. Be aged ≥60 years at the time of screening. 3. Presence of acquired memory complaints with a duration of \>3 months. Here we refer to memory/cognitive complaints in a broader sense that can involve other cognitive domains other than memory. (As reported by the participant or reliable trial informant. Trial informants can be a relative, spouse or domestic partner, or close friend who interacts closely enough with the participant to be able to respond to assessments/questionnaires as needed.) 4. Have a…
Interventions
- Dietary SupplementBrainXpert
sachet/stickpack of 25 g, has no preservatives, no flavors, no sweeteners, and no colorants.
- OtherPlacebo
high-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will also be provided in a powder format in a sachet/stickpack of 25 g.
Locations (30)
- Stein Gerontological Institute IncMiami, Florida
- University of RochesterRochester, New York
- Hôpital Pierre WertheimerBron
- CHU de Montpellier - Hôpital Gui de ChauliacMontpellier
- CHU de Nantes - Hôpital Nord LaennecNantes
- CHU de Toulouse - GerontopoleToulouse