|

The Ketogenic Diet for Alzheimer's Disease

RECRUITINGN/ASponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
PhaseN/A
SponsorAssistance Publique - Hôpitaux de Paris
Started2023-03-30
Est. completion2027-03
Eligibility
Age50 Years+
Healthy vol.Accepted

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

Age: 50 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age \>= 50
* AD confirmed by biomarkers (CSF and/or PET scan)
* CDR score=0.5 or 1
* Speaking/understanding French
* Presence of a caregiver

Exclusion Criteria:

* Diabetes
* Other neurological disease
* Chronic inflammatory disease or anti-inflammatory medication (e.g. NSAI, corticosteroids)
* Uncontrolled dyslipidemia
* Malnutrition (BMI \< 18; or weight loss \> 5% in 1 month or 10% in 6 months; or MNA \< 17)
* Severe chronic condition or organ dysfunction

Conditions2

Alzheimer Disease, Early OnsetAlzheimer's Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.