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

NCT06892418 | Completed

• 1 other identifier: PD23992
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Parkinson

Keywords

Parkinson's Disease; Ketogenic Diet; Intermittent Fasting; Ketoflex 12/3; Neurodegenerative Disorders

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 6 months

Study Arms (2)

Ketoflex 12/3 Diet Group

EXPERIMENTAL

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

Behavioral: Ketoflex 12/3 Diet

Control Group

NO INTERVENTION

Interventions

Ketoflex 12/3 Diet BEHAVIORAL

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

Ketoflex 12/3 Diet Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

İstanbul Medipol Üniversitesi

Istanbul, 34214, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Intermittent Fasting; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Fasting; Feeding Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 24, 2025
• Study Start: March 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

TU (1)