Crowborough

This research evaluates the effects of a nutritional intervention using ketogenic medium-chain triglycerides (kMCT) and B-vitamins on cognitive functioning in older adults who have mild cognitive impairment (MCI). The trial is designed as a prospective, randomized, double-blind, placebo-controlled, multi-center, and multi-country pivotal study. It aims to study cognitive changes in this population, particularly focusing on those with memory complaints lasting more than three months and clinical diagnoses consistent with MCI. Participants receive either BrainXpert, a dietary supplement sachet containing 25 g of ketogenic medium-chain triglycerides without preservatives or additives, or a placebo consisting of a calorie-equivalent non-ketogenic vegetable oil powder in a similar sachet form. The study includes multiple clinic visits over an 18-month period, with key assessments at randomization, 12 months, and 18 months. The placebo is high-oleic acid sunflower oil without added vitamins, ensuring blinding between groups. During the study, participants and their informants attend scheduled visits where cognitive performance is assessed, including the Preclinical Alzheimer's Cognitive Composite (PACC) score measured at 12 months. Researchers monitor participants' daily living autonomy, cognitive complaints, and compliance with the intervention. Safety and eligibility are closely observed, with attention to medication use and other health factors. The total involvement spans at least 18 months with multiple assessments to evaluate the nutritional intervention's impact on cognition.