RecruitingNot ApplicableNCT06347315

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)

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


Sponsor

Société des Produits Nestlé (SPN)

Enrollment

380 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BrainXpert and Placebo for people with mild cognitive impairment. The study is currently recruiting participants at 30 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(28)

Hôpital Pierre Wertheimer

Bron, France

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

CHU de Nantes - Hôpital Nord Laennec

Nantes, France

CHU de Toulouse - Gerontopole

Toulouse, France

Klinikum Bayreuth GmbH - Klinik Hohe Warte

Bayreuth, Germany

Studienzentrum für Neurologie und Psychiatrie

Böblingen, Germany

Neuro Centrum Science GmbH

Erbach im Odenwald, Germany

Universitaetsmedizin Ulm

Ulm, Germany

Foundation Institute G.Giglio

Cefalù, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

Palermo, Italy

AOU Policlinico Umberto I - Sapienza Università di Roma

Roma, Italy

Azienda Ospedaliera SantAndrea

Roma, Italy

Laboratory of Neuropsyichiatry, Fondazione Santa Lucia IRCCS

Roma, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

AO Card. G. Panico

Tricase, Italy

Hospital Universitario del Vinalopó

Alicante, Spain

Fundaciò ACE

Barcelona, Spain

HGU Gregorio Marañón

Madrid, Spain

Unidad de Investigación Neurociencias Centro de Salud San Juan

Salamanca, Spain

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Spain

Hospital Universitario Victoria Eugenia

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Universitare Altersmedizin FELIX PLATTER

Basel, Basel, Switzerland

Spitalzentrum Centre Hospitalier Biel-Bienne AG (SZB)

Biel, Switzerland

CHUV

Lausanne, Switzerland

Sussex Partnership NHS foundation Trust

Crowborough, United Kingdom

Hampshire & Isle of Wight Healthcare NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06347315


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