PreventionGOLDENNCT04440020
Management of Dementia With Olive Oil Leaves - GOLDEN
A study testing Beverage of Olive Oil Leaves and Mediterranean Diet in people with Prevention, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc).The olive leaves contain several phenolic compounds, most important of which are oleo-European… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Prevention
- What is being tested?
- Beverage of Olive Oil Leaves and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jan 2019to 10 Apr 2021
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Memory Complaints
- Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
- MMSE 18-24
- CDR(sum of boxes) >= 0,5
- Diagnosis: Mild Dementia (Alzheimer's Dementia)
- Geriatric Depression Scale (GDS) <6
Show all 11Show fewer
- Hachinski Modified Ischemic scale <= 4
- Stability of Permitted Medications for 4 weeks
- Years of education: >= 5
- Proficient language fluency
- Compliance
Who cannot join
- Visual and auditory acuity inadequate for neuropsychological testing
- Enrollment in other trials or studies not compatible with MICOIL
- History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
- Use of forbidden medications (listed below)
- Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
- Excluded Medication:
Show all 12Show fewer
- Antidepressants with anti-cholinergic properties.
- Regular use of narcotic analgesics (>2 doses per week) within 4 weeks of screening.
- Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.
- Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).
- Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.
- Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).
Trial locations and contacts
1 site in 1 country.
Greece1 site
Greek Associoation of Alzheimer'S Disease and Related Disorders
Thessaloniki, 54248
About this study
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc).The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances.
Read the detailed description
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc)
The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances. The benefits of eating olive leaves (juice, snack) are summarized as follows:
- Strengthen the immune system. It is the predominant benefit of drinking olive juice or beverage because of its active ingredient, oleo-European. Multi-pathogenic efficacy can be beneficial in treating influenza viruses, herpes simplex has been pathogenetically linked to Alzheimer's disease, yeasts (Yeast Syndrome), bacteria (11 species). Spectacular results have also been reported in the treatment of acute symptoms of AIDS by the administration of olive leaves. Also, neuroinflammation is one of the pathological mechanisms of Alzheimer's Disease
- Antioxidant action. Inhibition of oxidation of LDL cholesterol, caused by olive leaf oil, reduces the risk of developing cardiovascular disease. The simultaneous presence of "antioxidant" vitamin E that is abundant in olive leaves, further enhances this action. Oxidative stress is a proven causative factor for Alzheimer's disease.
- Antihypertensive action. Since the 1950s, there have been clinical data on the use of olive leaves in the treatment of hypertension through their vasodilatory action. One of the environmental risk factors for Alzheimer's Disease is also Hypertension.
- Inhibition of platelet aggregation. This property turns olive leaves into a major weapon for treating cardiovascular events and avoiding dangerous thrombi. Vascular cerebral or cardiac events are also vascular environmental factors of Alzheimer's Disease
- Increase in energy - Treatment of chronic fatigue. Consumption of olive leaves has been reported by many patients, but also by healthy people, that it gives more energy. This greater potency, potentially, can increase performance at work, performance in sport. Also, many cases of rapid recovery from chronic fatigue with frequent and systematic consumption of olive leaves have been reported. In short, they are a very important tool for modern and stressed man, the need for wellness and longevity.
One can easily observe the richness of olive leaves in trace elements, minerals - the role of Fe, Cu, Zn, Al and Hg in Alzheimer's disease is very important - and vitamins, making them a valuable nutritional tool for humans. At the same time, their fatty acid (saturated, monounsaturated, polyunsaturated) ratio is ideal and indicates their cardioprotective and neuroprotective properties.
The presence of vitamin E is twice as high as that found in a proportion of sesame oil (4.1 mg / 100gr), making the olive leaves a food rich in that vitamin. As far as iron is concerned, its presence is greater than the corresponding presence of breakfast cereals (8.2mg / 100gr), so advertised as a complete and quality food for the modern man.
Finally, particular reference should be made to the dietary fiber of the olive leaves. The dietary fiber is found in this food in abundance, making it a food that helps in the multifactorial treatment of constipation.
- Conditions
- Prevention
- Being tested
- Beverage of Olive Oil Leaves, Mediterranean Diet
- Keywords
- olive oil tree, leaves, Mild Dementia, prevention, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage of Olive Oil LeavesOther
Beverage of Olive Oil Leaves,Oleuropein
Mediterranean DietOther
Mediterranean Diet ,for a personal nutrition with the same dietary habits
| Study group | Role | What they receive |
|---|---|---|
| Beverage of Olive Oil Leaves | Experimental | 50 patients Beverage of Olive Oil Leaves Receives: Other: Beverage of Olive Oil Leaves |
| Mediterranean dietary protocol Intervention | Active comparator | 50 patients Dietary Supplement: Dietary Supplement:Mediterranean Diet Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Assessment - Measurements to Assess General Cognitive Function
Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24
Measured: baseline,24 months
FUCAS-Measurements to Assess Daily Functionality
Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42
Measured: baseline,24 months
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Letter \& Category Fluency Test
Measured: baseline,24 months
CDR- Measurements to Assess General Cognitive Function
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
Measured: baseline,24 months
MoCA- Measurements to Assess General Cognitive Function
Changes in Montreal Cognitive Assessment (MoCA)
Measured: baseline,24 months
Clock Drawing test- Measurements to Assess General Cognitive Function
Changes in the Clock Drawing test
Measured: baseline,24 months
Logical Memory test- Measurements to Assess General Cognitive Function
Changes in the Logical Memory test
Measured: baseline, 24 months
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Changes in the Digit Span Forward \& Backward test
Measured: baseline,24 months
WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function
Changes in the WAIS-R Digit Symbol Substitution Test
Measured: baseline,24 months
TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function
Changes in the Trail Making Test
Measured: baseline, 24 months
ADASCog-Measurements to Assess Daily Functionality
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) Score scale:0-70,cut off:<15
Measured: baseline, 24 months
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Changes in Functional Rating Scale for Dementia (FRSSD) Score scale:0-6,cut off:>6
Measured: baseline, 24 months
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Auditory Verbal Learning Test
Measured: baseline,24 months
Secondary outcomes (4)
NeuroImaging
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
Measured: baseline,24 months
CSF - beta amyloid
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
Measured: baseline,24 months
CSF(cerebrospinal fluid) TAU-protein ( soluble protein)
Changes in mean values on TAU-protein in cerebrospinal fluid
Measured: baseline,24 months
Electroencephalography recording
Changes in Electroencephalography (EEG), resting state.The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position
Measured: baseline,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start5 Jan 2019
- Primary completion10 Jan 2021 (estimated)
- Study completion10 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Model description
- Single Participant
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Tsolaki, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440020
- Sponsor's protocol ID
- ID: 46/6-2-19a
- Acronym
- GOLDEN
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.
PubMed 27472878Tzekaki EE, Tsolaki M, Pantazaki AA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. Administration of the extra virgin olive oil (EVOO) in mild cognitive impairment (MCI) patients as a therapy for preventing the progress to AD. Hell J Nucl Med. 2019 Sep-Dec;22 Suppl 2:181.
PubMed 31802059
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Dementia With Olive Oil Leaves - GOLDEN
- ClinicalTrials.gov ID
- NCT04440020
- Acronym / sponsor ID
- GOLDEN / ID: 46/6-2-19a
- Conditions
- Prevention
- Keywords
- olive oil tree, leaves, Mild Dementia, prevention, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 10 Jan 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 19 Jun 2020 (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.
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc).The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances.
Detailed description
Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc)
The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances. The benefits of eating olive leaves (juice, snack) are summarized as follows:
- Strengthen the immune system. It is the predominant benefit of drinking olive juice or beverage because of its active ingredient, oleo-European. Multi-pathogenic efficacy can be beneficial in treating influenza viruses, herpes simplex has been pathogenetically linked to Alzheimer's disease, yeasts (Yeast Syndrome), bacteria (11 species). Spectacular results have also been reported in the treatment of acute symptoms of AIDS by the administration of olive leaves. Also, neuroinflammation is one of the pathological mechanisms of Alzheimer's Disease
- Antioxidant action. Inhibition of oxidation of LDL cholesterol, caused by olive leaf oil, reduces the risk of developing cardiovascular disease. The simultaneous presence of "antioxidant" vitamin E that is abundant in olive leaves, further enhances this action. Oxidative stress is a proven causative factor for Alzheimer's disease.
- Antihypertensive action. Since the 1950s, there have been clinical data on the use of olive leaves in the treatment of hypertension through their vasodilatory action. One of the environmental risk factors for Alzheimer's Disease is also Hypertension.
- Inhibition of platelet aggregation. This property turns olive leaves into a major weapon for treating cardiovascular events and avoiding dangerous thrombi. Vascular cerebral or cardiac events are also vascular environmental factors of Alzheimer's Disease
- Increase in energy - Treatment of chronic fatigue. Consumption of olive leaves has been reported by many patients, but also by healthy people, that it gives more energy. This greater potency, potentially, can increase performance at work, performance in sport. Also, many cases of rapid recovery from chronic fatigue with frequent and systematic consumption of olive leaves have been reported. In short, they are a very important tool for modern and stressed man, the need for wellness and longevity.
One can easily observe the richness of olive leaves in trace elements, minerals - the role of Fe, Cu, Zn, Al and Hg in Alzheimer's disease is very important - and vitamins, making them a valuable nutritional tool for humans. At the same time, their fatty acid (saturated, monounsaturated, polyunsaturated) ratio is ideal and indicates their cardioprotective and neuroprotective properties.
The presence of vitamin E is twice as high as that found in a proportion of sesame oil (4.1 mg / 100gr), making the olive leaves a food rich in that vitamin. As far as iron is concerned, its presence is greater than the corresponding presence of breakfast cereals (8.2mg / 100gr), so advertised as a complete and quality food for the modern man.
Finally, particular reference should be made to the dietary fiber of the olive leaves. The dietary fiber is found in this food in abundance, making it a food that helps in the multifactorial treatment of constipation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Participant
| Arm | Type | Receives |
|---|---|---|
| Beverage of Olive Oil Leaves | Experimental | Other: Beverage of Olive Oil Leaves50 patients Beverage of Olive Oil Leaves |
| Mediterranean dietary protocol Intervention | Active comparator | Other: Mediterranean Diet50 patients Dietary Supplement: Dietary Supplement:Mediterranean Diet |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Memory Complaints
- Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
- MMSE 18-24
- CDR(sum of boxes) >= 0,5
- Diagnosis: Mild Dementia (Alzheimer's Dementia)
Key exclusion criteria (12 listed)
- Visual and auditory acuity inadequate for neuropsychological testing
- Enrollment in other trials or studies not compatible with MICOIL
- History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
- Use of forbidden medications (listed below)
- Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
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 |
|---|---|---|
| Beverage of Olive Oil LeavesBeverage of Olive Oil Leaves,Oleuropein | Other | Beverage of Olive Oil Leaves |
| Mediterranean DietMediterranean Diet ,for a personal nutrition with the same dietary habits | Other | Mediterranean dietary protocol Intervention |
Primary outcome
Neuropsychological Assessment - Measurements to Assess General Cognitive Function
Time frame: baseline,24 months
Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24
FUCAS-Measurements to Assess Daily Functionality
Time frame: baseline,24 months
Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Time frame: baseline,24 months
Changes in the Letter \& Category Fluency Test
CDR- Measurements to Assess General Cognitive Function
Time frame: baseline,24 months
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
MoCA- Measurements to Assess General Cognitive Function
Time frame: baseline,24 months
Changes in Montreal Cognitive Assessment (MoCA)
Clock Drawing test- Measurements to Assess General Cognitive Function
Time frame: baseline,24 months
Changes in the Clock Drawing test
Logical Memory test- Measurements to Assess General Cognitive Function
Time frame: baseline, 24 months
Changes in the Logical Memory test
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Time frame: baseline,24 months
Changes in the Digit Span Forward \& Backward test
WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function
Time frame: baseline,24 months
Changes in the WAIS-R Digit Symbol Substitution Test
TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function
Time frame: baseline, 24 months
Changes in the Trail Making Test
ADASCog-Measurements to Assess Daily Functionality
Time frame: baseline, 24 months
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) Score scale:0-70,cut off:<15
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Time frame: baseline, 24 months
Changes in Functional Rating Scale for Dementia (FRSSD) Score scale:0-6,cut off:>6
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Time frame: baseline,24 months
Changes in the Auditory Verbal Learning Test
4 secondary outcomes
NeuroImaging
Time frame: baseline,24 months
CSF - beta amyloid
Time frame: baseline,24 months
CSF(cerebrospinal fluid) TAU-protein ( soluble protein)
Time frame: baseline,24 months
Electroencephalography recording
Time frame: baseline,24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Results publication: PubMed 27472878Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.
- Results publication: PubMed 31802059Tzekaki EE, Tsolaki M, Pantazaki AA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. Administration of the extra virgin olive oil (EVOO) in mild cognitive impairment (MCI) patients as a therapy for preventing the progress to AD. Hell J Nucl Med. 2019 Sep-Dec;22 Suppl 2:181.
- Individual participant dataSharing planned: Undecided
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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 Beverage of Olive Oil Leaves and Mediterranean Diet in people with Prevention, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Jun 2020. 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 Greece. 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?
Results are not available in the source record.
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?
Neuropsychological Assessment - Measurements to Assess General Cognitive Function (time frame: baseline,24 months). The study lists 13 primary outcomes in all. 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 NCT04440020, which also lists 2 linked publications.
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 19 Jun 2020.