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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Age \>= 50

• AD confirmed by biomarkers (CSF and/or PET scan)

• CDR score=0.5 or 1

• Speaking/understanding French

• Presence of a caregiver

Locations
Other Locations
France
Cognitive Neurology Center - Lariboisière Fernand Widal University Hospital (APHP)
RECRUITING
Paris
Contact Information
Primary
LILAMAND Matthieu, MD PhD
matthieu.lilamand@aphp.fr
+33140054954
Time Frame
Start Date: 2023-03-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 70
Treatments
Experimental: Modified Atkins 2 :1 Ketogenic 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
No_intervention: Control diet
Related Therapeutic Areas
Sponsors
Collaborators: France Alzheimer
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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