Alzheimer Type DementiaNCT06898424
Impact of Ketoflex 12/3 Diet on Early-to-Mid Stage Alzheimer's Progression
A study testing Ketoflex 12/3 Diet in people with Alzheimer Type Dementia and Alzheimer's Disease (AD), run by Prof. Lutfu Hanoglu, MD at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Type Dementia, Alzheimer's Disease (AD)
- 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
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 31 Oct 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50-85 years
- Clinical Dementia Rating (CDR) score of 1 or2
- Diagnosis of Alzheimer's disease (AD) according to NIA-AA criteria
Who cannot join
- Alcohol and/or substance dependence
- Diagnosis of chronic renal failure
- Diagnosis of another neuropsychiatric disorder
- Presence of amalgam dental fillings and/or failure to have them removed following the SMART protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Concurrent Plant-Based Ketogenic Diet and Intermittent Fasting (Ketoflex 12/3) on the Clinical Progression of Early-to-Mid Stage Alzheimer's Dementia
This study investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol.
- Being tested
- Ketoflex 12/3 Diet
- Keywords
- Alzheimer's Disease, Ketogenic Diet, Intermittent Fasting, Ketoflex 12/3, Cognitive Decline, Neurodegeneration
- Medical subject headings
- Alzheimer Disease, Intermittent Fasting, Cognitive Dysfunction, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoflex 12/3 DietBehavioural
plant-based ketogenic diet combined with intermittent fasting (12/3)
| Study group | Role | What they receive |
|---|---|---|
| Ketoflex 12/3 Diet Group | Experimental | Participants follow the Ketoflex 12/3 dietary protocol. Receives: Behavioral: Ketoflex 12/3 Diet |
| Control Group | No intervention | Participants continue their usual diet with no modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function as Measured by the MMSE Score
Mini-Mental State Examination (MMSE) will be used to assess cognitive function before and after the intervention.
The Mini-Mental State Examination (MMSE) is used to assess cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
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 posted27 Mar 2025
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Type DementiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Lutfu Hanoglu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Lutfu Hanoglu, MD, Istanbul Medipol University Hospital
- Investigators
- Lütfü Hanoğlu, Prof. MD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898424
- Sponsor's protocol ID
- ALZ23992
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 24 Mar 2026
- 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
Publications
Tagraf B, Kaygusuz D, Yerlikaya D, Ogul OE, Hanoglu L. The effect of simultaneous application of plant-rich ketogenic diet and intermittent fasting on early-to-mid-stage Alzheimer's disease: a randomised controlled trial. J Nutr Health Aging. 2026 Jul 24;30(9):100930. doi: 10.1016/j.jnha.2026.100930. Online ahead of print.
PubMed 42497811
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Plant-Based Ketogenic Diet and Intermittent Fasting (Ketoflex 12/3) on the Clinical Progression of Early-to-Mid Stage Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT06898424
- Acronym / sponsor ID
- ALZ23992
- Keywords
- Alzheimer's Disease, Ketogenic Diet, Intermittent Fasting, Ketoflex 12/3, Cognitive Decline, Neurodegeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Lutfu Hanoglu, MDUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 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 investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol.
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 DietParticipants follow the Ketoflex 12/3 dietary protocol. |
| Control Group | No intervention | –Participants continue their usual diet with no modifications |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 50-85 years
- Clinical Dementia Rating (CDR) score of 1 or2
- Diagnosis of Alzheimer's disease (AD) according to NIA-AA criteria
Key exclusion criteria (4 listed)
- Alcohol and/or substance dependence
- Diagnosis of chronic renal failure
- Diagnosis of another neuropsychiatric disorder
- Presence of amalgam dental fillings and/or failure to have them removed following the SMART protocol
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 Dietplant-based ketogenic diet combined with intermittent fasting (12/3) | Behavioural | Ketoflex 12/3 Diet Group |
Primary outcome
Change in Cognitive Function as Measured by the MMSE Score
Time frame: Baseline and 6 months
Mini-Mental State Examination (MMSE) will be used to assess cognitive function before and after the intervention. The Mini-Mental State Examination (MMSE) is used to assess cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
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 24 Mar 2026.
- Derived from this study: PubMed 42497811Tagraf B, Kaygusuz D, Yerlikaya D, Ogul OE, Hanoglu L. The effect of simultaneous application of plant-rich ketogenic diet and intermittent fasting on early-to-mid-stage Alzheimer's disease: a randomised controlled trial. J Nutr Health Aging. 2026 Jul 24;30(9):100930. doi: 10.1016/j.jnha.2026.100930. Online ahead of print.
- 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.
Lütfü Hanoğlu, Prof. MD principal investigator
Medipol University
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 Alzheimer Type Dementia and Alzheimer's Disease (AD), run by Prof. Lutfu Hanoglu, MD 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 3 inclusion and 4 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 24 Mar 2026. 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 Cognitive Function as Measured by the MMSE Score (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?
On the ClinicalTrials.gov record for NCT06898424, which also lists 1 linked publication.
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 24 Mar 2026.