Study of a Nutritional Intervention Using Ketogenic Medium-chain Triglycerides and B-vitamins to Improve Cognitive Function in Older Adults with Mild Cognitive Impairment

What this Trial Is About

Researchers are studying the effects of a nutritional intervention combining ketogenic medium-chain triglycerides kMCT and B-vitamins on cognitive function in older adults diagnosed with mild cognitive impairment MCI. This randomized, double-blind, placebo-controlled trial aims to evaluate how this nutritional approach impacts cognitive performance over a 12-month period. The study is sponsored by Socit des Produits Nestl and involves multiple centers and countries. Participants will be randomly assigned to receive either BrainXpert, a dietary supplement containing 15 g of kMCT and B-vitamins in powder form, or a placebo consisting of a calorie-equivalent, non-ketogenic high-oleic acid sunflower oil powder. Both are provided in sachetstickpack format without preservatives, flavors, sweeteners, or colorants. The intervention is administered daily during the study period. During the trial, participants and their informants will attend clinic visits at baseline, 12 months, and 18 months. Cognitive function will be assessed using tools such as the Preclinical Alzheimers Cognitive Composite PACC, Montreal Cognitive Assessment MoCA, Wechsler Memory Scale, and Mini-Mental State Examination MMSE. Safety and tolerability will also be monitored throughout the 12 months. The study includes adherence assessments and requires participants to comply with study procedures and medication restrictions.

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)