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

March 19, 2026 updated by: Prof. Lutfu Hanoglu, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34214
        • İstanbul Medipol Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketoflex 12/3 Diet Group
Participants follow the Ketoflex 12/3 dietary protocol.
Behavioral: Ketoflex 12/3 Diet
plant-based ketogenic diet combined with intermittent fasting (12/3)
No Intervention: Control Group
Participants continue their usual diet with no modifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Lutfu Hanoglu, MD

Investigators

  • Principal Investigator: Lütfü Hanoğlu, Prof. MD, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALZ23992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this time, no final decision has been made regarding individual participant data (IPD) sharing. Future data-sharing plans will be considered in accordance with institutional policies, ethical guidelines, and publication requirements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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