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

NCT ID: NCT06898424

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Type Dementia Alzheimer's Disease (AD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ketoflex 12/3 Diet Group

Participants follow the Ketoflex 12/3 dietary protocol.

Group Type EXPERIMENTAL

Ketoflex 12/3 Diet

Intervention Type BEHAVIORAL

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

Control Group

Participants continue their usual diet with no modifications

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ketoflex 12/3 Diet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 50-85 years
* Clinical Dementia Rating (CDR) score of 0.5 or 1
* Diagnosis of Alzheimer's disease (AD) according to NINCDS-ADRDA 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Lutfu Hanoglu, MD

OTHER

Sponsor Role lead

Responsible Party

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Prof. Lutfu Hanoglu, MD

Prof. MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lütfü Hanoğlu, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

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Istanbul Medipol Universitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ALZ23992

Identifier Type: -

Identifier Source: org_study_id

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