RecruitingNAINTERVENTIONAL

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)

This study, called COGNIKET-MCI, is investigating a nutritional drink designed to support brain health. It contains special fats called ketogenic medium-chain triglycerides and B-vitamins. The main goal is to find out if taking this drink can improve thinking skills, memory, and overall brain function in older adults who have mild cognitive impairment. Participants will receive either the active drink or a look-alike dummy drink (placebo), so researchers can compare the effects fairly. This research aims to understand if specific nutrients can play a role in managing age-related changes in brain function and help people maintain their cognitive abilities as they get older.

At a glance

Status

Recruiting

Phase

Sponsor

Société des Produits Nestlé (SPN)

Enrolment target

380

Start

24 May 2024

Estimated completion

15 Dec 2027

Mild Cognitive Impairment

What is this study about?

This study, named COGNIKET-MCI, is looking into how a specific nutritional support might help older adults who are experiencing mild cognitive impairment. Mild cognitive impairment means that someone has noticed some changes in their memory or thinking skills, but these changes are not severe enough to affect their daily life significantly. It's often seen as a stage between normal aging and more serious memory problems like dementia.

The nutritional support being tested contains two main components: ketogenic medium-chain triglycerides (MCTs) and B-vitamins. MCTs are a type of fat that the body can use for energy in a different way than other fats, and some research suggests they might be helpful for brain cells. B-vitamins are important for many bodily functions, including brain health.

Researchers want to see if regularly taking this nutritional drink can make a positive difference in memory, problem-solving, and other thinking abilities for people with mild cognitive impairment. By comparing it to a dummy treatment (placebo), they can tell if any changes are truly due to the active ingredients or other factors. This research could help us better understand ways to support brain health as we age.

Key takeaways

Tests a nutritional drink (MCTs + B-vitamins) for mild cognitive impairment.
Compares the active drink to a dummy drink (placebo).
Aims to see if thinking and memory improve over 18 months.
Requires a close friend or family member to support your participation.
Involves regular clinic visits and memory assessments.

Who may be eligible?

To join this study, you need to be at least 60 years old and have signed a consent form saying you understand and agree to take part. You should have noticed some memory problems for more than three months, and a doctor must have diagnosed you with mild cognitive impairment. This diagnosis often includes specific types, such as those related to Alzheimer's disease or certain blood vessel conditions that don't come from a stroke.

Your daily activities, such as managing money or cooking, should not be significantly affected by your memory issues. This is called having "full autonomy for daily living." Also, you'll need to have a trusted friend or family member, called a "trial informant," who knows you well. This person will need to come with you to some appointments and answer questions about your memory and daily life. They should spend at least two hours a day, at least four times a week, with you.

Both you and your informant should be able to read and write clearly, and have good enough vision and hearing to participate in tests and conversations. The study will also check your scores on specific memory and thinking tests to make sure your level of cognitive impairment matches what they are looking for.

Quick self-check

Are you 60 years old or older?
Have you noticed memory problems for more than 3 months?
Has a doctor diagnosed you with mild cognitive impairment?
Can you manage your daily activities independently?
Do you have a close friend or family member who can attend some appointments with you and answer questions?
Are you able to read and write easily, with good vision and hearing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given either the special nutritional drink (BrainXpert) or a dummy drink (placebo). You won't know which one you're getting, and neither will the study team, to ensure fair results. You'll need to attend several visits to the clinic over a period of time. Your trial informant (a trusted friend or family member) will need to come with you to three specific visits: the first visit (when you start), a visit after 12 months, and a final visit after 18 months.

During these visits, you will have various assessments to check your memory, thinking skills, and overall health. These might include questionnaires, memory tests, and possibly other check-ups. The nutritional drink or placebo will be taken regularly as instructed, and the study will track any changes over the full 18-month duration. There will be clear instructions on how and when to take your assigned drink.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. You might benefit from closer medical attention and monitoring throughout the study. If the nutritional drink is effective, you might experience improvements in your thinking and memory. However, there's no guarantee that you will personally benefit from taking part. Potential risks might include mild side effects from the drink, though these would be thoroughly explained before you start. There's also the time commitment required for clinic visits and taking the study product. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Stein Gerontological Institute Inc
Miami, United States· Not yet recruiting
University of Rochester
Rochester, United States· Not yet recruiting
Hôpital Pierre Wertheimer
Bron, France· Recruiting
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, France· Recruiting
CHU de Nantes - Hôpital Nord Laennec
Nantes, France· Recruiting
CHU de Toulouse - Gerontopole
Toulouse, France· Recruiting
Klinikum Bayreuth GmbH - Klinik Hohe Warte
Bayreuth, Germany· Recruiting
Studienzentrum für Neurologie und Psychiatrie
Böblingen, Germany· Recruiting
Neuro Centrum Science GmbH
Erbach im Odenwald, Germany· Recruiting
Universitaetsmedizin Ulm
Ulm, Germany· Recruiting
Foundation Institute G.Giglio
Cefalù, Italy· Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, Italy· Recruiting

+18 more sites — see the official record for the full list.

Common questions

What is mild cognitive impairment (MCI)?

MCI means you have some memory or thinking problems noticeable to you and others, but they're not severe enough to stop you from doing your daily activities.

What is in the BrainXpert drink?

It contains special fats called ketogenic medium-chain triglycerides (MCTs) and B-vitamins, which researchers are testing for brain health.

What is a placebo?

A placebo is a dummy treatment that looks and tastes like the real one but contains no active ingredients. It helps researchers compare effects accurately.

Who is a 'trial informant'?

A trial informant is a close friend or family member who knows you well and can answer questions about your memory and daily life for the study.

How long does the study last?

The study lasts for 18 months, during which you'll have regular check-ups and take the assigned drink.

How to find out more

Monique Bunyan

monique.bunyan@uk.nestle.com +44 7833 293 097 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.