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

NCT06898424 | Completed

• 1 other identifier: ALZ23992
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Type Dementia; Alzheimer's Disease (AD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function as Measured by the MMSE Score

  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.

  Baseline and 6 months

Study Arms (2)

Ketoflex 12/3 Diet Group

EXPERIMENTAL

Participants follow the Ketoflex 12/3 dietary protocol.

Behavioral: Ketoflex 12/3 Diet

Control Group

NO INTERVENTION

Participants continue their usual diet with no modifications

Interventions

Ketoflex 12/3 Diet BEHAVIORAL

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

Ketoflex 12/3 Diet Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Lutfu Hanoglu, MD: lead

Study Sites (1)

Istanbul Medipol Universitesi

Istanbul, 34214, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease; Intermittent Fasting; Cognitive Dysfunction; Nerve Degeneration

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Fasting; Feeding Behavior; Behavior; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lütfü Hanoğlu, Prof. MD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: March 24, 2026

Record last verified: 2025-03

Locations

TU (1)