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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06898424
Enrollment
60
Registered
2025-03-27
Start date
2024-03-01
Completion date
2024-10-31
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease (AD), Alzheimer Type Dementia

Keywords

Alzheimer's Disease, Ketogenic Diet, Intermittent Fasting, Ketoflex 12/3, Cognitive Decline, Neurodegeneration

Brief summary

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.

Interventions

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

Sponsors

Prof. Lutfu Hanoglu, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive Function as Measured by the MMSE ScoreBaseline and 6 monthsMini-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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORLütfü Hanoğlu, Prof. MD

Medipol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 26, 2026