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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Fasting Feeding Behavior Intermittent Fasting Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Medipol Üniversitesi

Istanbul, 34214, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketoflex 12/3 Diet

Behavioral

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

Primary outcomes

Change in Motor Symptoms as Measured by the Unified Parkinson's Disease Rating Scale (UPDRS)

Time frame: Baseline and 6 months

The Unified Parkinson's Disease Rating Scale (UPDRS) is used to evaluate the severity of motor symptoms in Parkinson's disease. Scores range from 0 to 108 for the motor section, with higher scores indicating worse motor impairment.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

A Clinical Study on the Effects of Ketoflex 12/3 Diet on Motor and Non-Motor Symptoms in Patients With Parkinson's Disease

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Mar 24, 2025
Registry last updated: Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed