RecruitingNot ApplicableNCT04701957

The Ketogenic Diet for Alzheimer's Disease

The Ketogenic Diet for Alzheimer's Disease: a Randomized Controlled Feasibility Study.


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

70 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The ketogenic diet (KD) is a metabolic shift, which stimulates the liver oxidation of fatty acids to produce ketone bodies. These ketone bodies represent an alternative fuel source for the brain. The benefits of KD in epilepsia have been demonstrated for decades. This diet may also provide benefits in Alzheimer's disease (AD) where neuronal glucose utilization declines from the early stage. Besides, the KD could decrease neuroinflammation, oxidative stress and enhance mitochondrial biogenesis. In murin models of AD, KD or Medium Chain Triglycerides consumption were associated with lower neuroinflammation but also with a diminution of neuropathologic features of AD (amyloid and tau lesions in the brain). Moreover, behavioural effets and improvements in memory and motor function have been highlighted. In humans, recent studies suggest cognitive benefits (memory, executive function) in AD, including in the Mild Cognitive Impairment (MCI) stage. The feasibility and the adherence to the diet proved to be correct, in small samples, in particular in MCI individuals over a short follow-up period (3 to 6 months). This study aims at examining the feasibility of a KD followed-up for one year in participants with early AD (N=70). Change in brain metabolism will be assessed using PET scan after 12 months, comparing KD with control diet. The effects on cognition, quality of life and daily living functioning will be analysed. The safety, nutritional changes and adhesion to the diet will be monitored throughout the study.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketogenic diet (a very low-carbohydrate, high-fat diet) can slow the progression of Alzheimer's disease. Researchers want to see if changing the brain's fuel source from sugar to ketones can help preserve memory and thinking. **You may be eligible if...** - You are 50 or older - You have confirmed Alzheimer's disease (via spinal fluid or PET scan biomarkers) - Your disease is mild (CDR score of 0.5 or 1) - You speak and understand French - You have a caregiver who can support you during the diet **You may NOT be eligible if...** - You have diabetes - You have another neurological disease - You are taking anti-inflammatory medications (such as NSAIDs or corticosteroids) - You have uncontrolled high cholesterol or are malnourished - You have severe organ problems or another serious chronic condition Talk to your doctor to see if this trial is right for you.

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

BEHAVIORALKetogenic diet

The Atkins 2: 1 diet as prescribed for the participants of our intervention group (N = 35) is based on a diet moderately rich in protein (meat, fish, cheese, eggs, vegetable proteins) and without restriction of fats, provided they are balanced, but limiting the carbohydrate intake (bread, pasta, rice) to 50 grams / day. The ratio calories from fat / calories from protein + carbohydrates will be 3 to 1


Locations(1)

Cognitive Neurology Center - Lariboisière Fernand Widal University Hospital (APHP)

Paris, France

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NCT04701957


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