Impact of Ketoflex 12/3 Diet on Early-to-Mid Stage Alzheimer's Progression

This study investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Type Dementia Alzheimer Disease Alzheimer's Disease (AD) Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Fasting Feeding Behavior Intermittent Fasting Mental Disorders Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol Universitesi

Istanbul, 34214, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 50-85 years
Clinical Dementia Rating (CDR) score of 1 or2
Diagnosis of Alzheimer's disease (AD) according to NIA-AA criteria

Exclusion criteria

Alcohol and/or substance dependence
Diagnosis of chronic renal failure
Diagnosis of another neuropsychiatric disorder
Presence of amalgam dental fillings and/or failure to have them removed following the SMART protocol

Treatment and study plan

Ketoflex 12/3 Diet

Behavioral

plant-based ketogenic diet combined with intermittent fasting (12/3)

Primary outcomes

Change in Cognitive Function as Measured by the MMSE Score

Time frame: Baseline and 6 months

Mini-Mental State Examination (MMSE) will be used to assess cognitive function before and after the intervention.

The Mini-Mental State Examination (MMSE) is used to assess cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.

Sponsors and collaborators

Lead sponsor

Prof. Lutfu Hanoglu, MD

Other

Registry information

Official study title

Effects of Concurrent Plant-Based Ketogenic Diet and Intermittent Fasting (Ketoflex 12/3) on the Clinical Progression of Early-to-Mid Stage Alzheimer's Dementia

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Mar 27, 2025
Registry last updated: Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed