Impact of Ketoflex 12/3 Diet on Parkinson's Disease Sympt... | NCT06892418

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

NCT06892418

Sponsor

Istanbul Medipol University Hospital

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Parkinson's Disease
Parkinson

Interventions

Ketoflex 12/3 Diet

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2024Actual

Primary Completion Date

Oct 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Mar 21, 2025

First Submission Date that Met QC Criteria

Mar 21, 2025

First Posted Date

Mar 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Lutfu Hanoglu, MD, Professor.MD.PhD, Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ketoflex 12/3 Diet	Behavioral	A plant-based ketogenic diet combined with intermittent fasting (12/3)	Ketoflex 12/3 Diet Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
İstanbul Medipol Üniversitesi		Istanbul		34214	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D000093763	Intermittent Fasting
D019636	Neurodegenerative Diseases

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided