Parkinson's DiseaseNCT06892418
Impact of Ketoflex 12/3 Diet on Parkinson's Disease Symptoms: A Clinical Study
A study testing Ketoflex 12/3 Diet in people with Parkinson's Disease and Parkinson, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease, Parkinson
- What is being tested?
- Ketoflex 12/3 Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Parkinson's disease
- Age between 40-85 years
- Native Turkish speakers
- Able to comply with the study protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study on the Effects of Ketoflex 12/3 Diet on Motor and Non-Motor Symptoms in Patients With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson's Disease, Parkinson
- Being tested
- Ketoflex 12/3 Diet
- Keywords
- Parkinson's Disease, Ketogenic Diet, Intermittent Fasting, Ketoflex 12/3, Neurodegenerative Disorders
- Medical subject headings
- Parkinson Disease, Intermittent Fasting, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoflex 12/3 DietBehavioural
A plant-based ketogenic diet combined with intermittent fasting (12/3)
| Study group | Role | What they receive |
|---|---|---|
| Ketoflex 12/3 Diet Group | Experimental | A plant-based ketogenic diet combined with intermittent fasting (12/3) Receives: Behavioral: Ketoflex 12/3 Diet |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start30 Mar 2024
- Primary completion30 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lutfu Hanoglu, MD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892418
- Sponsor's protocol ID
- PD23992
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effects of Ketoflex 12/3 Diet on Motor and Non-Motor Symptoms in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06892418
- Acronym / sponsor ID
- PD23992
- Conditions
- Parkinson's Disease, Parkinson
- Keywords
- Parkinson's Disease, Ketogenic Diet, Intermittent Fasting, Ketoflex 12/3, Neurodegenerative Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoflex 12/3 Diet Group | Experimental | Behavioral: Ketoflex 12/3 DietA plant-based ketogenic diet combined with intermittent fasting (12/3) |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Parkinson's disease
- Age between 40-85 years
- Native Turkish speakers
- Able to comply with the study protocol
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketoflex 12/3 DietA plant-based ketogenic diet combined with intermittent fasting (12/3) | Behavioural | Ketoflex 12/3 Diet Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketoflex 12/3 Diet in people with Parkinson's Disease and Parkinson, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Symptoms as Measured by the Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.