Impact of Ketoflex 12/3 Diet on Parkinson's Disease Symptoms: A Clinical Study

NCT ID: NCT06892418

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2024-11-30

Brief Summary

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This study aims to investigate the effects of the Ketoflex 12/3 diet on motor and non-motor symptoms in patients with Parkinson's disease. Participants will follow the Ketoflex 12/3 dietary regimen, and their cognitive function, motor symptoms, sleep patterns, gastrointestinal health, and overall well-being will be assessed through standardized clinical scales. The study will help determine whether a plant-based ketogenic diet combined with intermittent fasting can have a beneficial impact on Parkinson's disease progression.

Detailed Description

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Parkinson's disease is a progressive neurodegenerative disorder characterized by motor and non-motor symptoms. Emerging evidence suggests that dietary interventions, particularly ketogenic diets and intermittent fasting, may play a role in neuroprotection and symptom management. This study investigates the effects of the Ketoflex 12/3 diet, a plant-based ketogenic dietary approach combined with intermittent fasting, on Parkinson's disease progression. Clinical assessments will include Unified Parkinson's Disease Rating Scale (UPDRS), Mini-Mental State Examination (MMSE), depression and anxiety scales, sleep quality assessments, and gastrointestinal health evaluations. The study aims to provide new insights into the potential benefits of metabolic-based nutritional interventions in Parkinson's disease patients.

Conditions

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Parkinson's Disease Parkinson

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

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

Group Type EXPERIMENTAL

Ketoflex 12/3 Diet

Intervention Type BEHAVIORAL

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ketoflex 12/3 Diet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Parkinson's disease
* Age between 40-85 years
* Native Turkish speakers
* Able to comply with the study protocol

Exclusion Criteria

* History of alcohol or substance dependence
* Diagnosis of chronic renal failure
* Presence of neuromuscular disorders
* Having amalgam dental fillings and/or failure to remove them according to the SMART protocol
* Severe vitamin deficiencies that have not been corrected prior to the study
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Lutfu Hanoglu, MD

Professor.MD.PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İstanbul Medipol Üniversitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PD23992

Identifier Type: -

Identifier Source: org_study_id

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