Management of Dementia With Olive Oil Leaves - GOLDEN (GOLDEN)
Primary Purpose
Prevention
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Beverage of Olive Oil Leaves
Mediterranean Diet
Sponsored by
About this trial
This is an interventional prevention trial for Prevention focused on measuring olive oil tree, leaves, Mild Dementia, prevention, Alzheimer's disease
Eligibility Criteria
Inclusion Criteria:
- 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
- Hachinski Modified Ischemic scale <= 4
- Stability of Permitted Medications for 4 weeks
- Years of education: >= 5
- Proficient language fluency
- Compliance
Exclusion Criteria:
- 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:
- 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).
Sites / Locations
- Greek Associoation of Alzheimer'S Disease and Related Disorders
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Beverage of Olive Oil Leaves
Mediterranean dietary protocol Intervention
Arm Description
50 patients Beverage of Olive Oil Leaves
50 patients Dietary Supplement: Dietary Supplement:Mediterranean Diet
Outcomes
Primary Outcome Measures
Neuropsychological Assessment - Measurements to Assess General Cognitive Function
Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24
FUCAS-Measurements to Assess Daily Functionality
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
Changes in the Letter & Category Fluency Test
CDR- Measurements to Assess General Cognitive Function
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
MoCA- Measurements to Assess General Cognitive Function
Changes in Montreal Cognitive Assessment (MoCA)
Clock Drawing test- Measurements to Assess General Cognitive Function
Changes in the Clock Drawing test
Logical Memory test- Measurements to Assess General Cognitive Function
Changes in the Logical Memory test
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Changes in the Digit Span Forward & Backward test
WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function
Changes in the WAIS-R Digit Symbol Substitution Test
TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function
Changes in the Trail Making Test
ADASCog-Measurements to Assess Daily Functionality
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
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
Changes in the Auditory Verbal Learning Test
Secondary Outcome Measures
NeuroImaging
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
CSF - beta amyloid
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
CSF(cerebrospinal fluid) TAU-protein ( soluble protein)
Changes in mean values on TAU-protein in cerebrospinal fluid
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
Full Information
NCT ID
NCT04440020
First Posted
June 10, 2020
Last Updated
June 18, 2020
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT04440020
Brief Title
Management of Dementia With Olive Oil Leaves - GOLDEN
Acronym
GOLDEN
Official Title
Management of Dementia With Olive Oil Leaves - GOLDEN
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
January 10, 2021 (Anticipated)
Study Completion Date
April 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention
Keywords
olive oil tree, leaves, Mild Dementia, prevention, Alzheimer's disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single Participant
Masking
Participant
Masking Description
single (participant)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beverage of Olive Oil Leaves
Arm Type
Experimental
Arm Description
50 patients Beverage of Olive Oil Leaves
Arm Title
Mediterranean dietary protocol Intervention
Arm Type
Active Comparator
Arm Description
50 patients Dietary Supplement: Dietary Supplement:Mediterranean Diet
Intervention Type
Other
Intervention Name(s)
Beverage of Olive Oil Leaves
Intervention Description
Beverage of Olive Oil Leaves,Oleuropein
Intervention Type
Other
Intervention Name(s)
Mediterranean Diet
Intervention Description
Mediterranean Diet ,for a personal nutrition with the same dietary habits
Primary Outcome Measure Information:
Title
Neuropsychological Assessment - Measurements to Assess General Cognitive Function
Description
Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24
Time Frame
baseline,24 months
Title
FUCAS-Measurements to Assess Daily Functionality
Description
Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42
Time Frame
baseline,24 months
Title
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Description
Changes in the Letter & Category Fluency Test
Time Frame
baseline,24 months
Title
CDR- Measurements to Assess General Cognitive Function
Description
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
Time Frame
baseline,24 months
Title
MoCA- Measurements to Assess General Cognitive Function
Description
Changes in Montreal Cognitive Assessment (MoCA)
Time Frame
baseline,24 months
Title
Clock Drawing test- Measurements to Assess General Cognitive Function
Description
Changes in the Clock Drawing test
Time Frame
baseline,24 months
Title
Logical Memory test- Measurements to Assess General Cognitive Function
Description
Changes in the Logical Memory test
Time Frame
baseline, 24 months
Title
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Description
Changes in the Digit Span Forward & Backward test
Time Frame
baseline,24 months
Title
WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function
Description
Changes in the WAIS-R Digit Symbol Substitution Test
Time Frame
baseline,24 months
Title
TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function
Description
Changes in the Trail Making Test
Time Frame
baseline, 24 months
Title
ADASCog-Measurements to Assess Daily Functionality
Description
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) Score scale:0-70,cut off:<15
Time Frame
baseline, 24 months
Title
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Description
Changes in Functional Rating Scale for Dementia (FRSSD) Score scale:0-6,cut off:>6
Time Frame
baseline, 24 months
Title
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Description
Changes in the Auditory Verbal Learning Test
Time Frame
baseline,24 months
Secondary Outcome Measure Information:
Title
NeuroImaging
Description
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
Time Frame
baseline,24 months
Title
CSF - beta amyloid
Description
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
Time Frame
baseline,24 months
Title
CSF(cerebrospinal fluid) TAU-protein ( soluble protein)
Description
Changes in mean values on TAU-protein in cerebrospinal fluid
Time Frame
baseline,24 months
Title
Electroencephalography recording
Description
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
Time Frame
baseline,24 months
Other Pre-specified Outcome Measures:
Title
Weight in Kilograms
Description
Changes in weight
Time Frame
baseline,24 months
Title
Height in Meters
Description
Changes in Height
Time Frame
baseline,24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Hachinski Modified Ischemic scale <= 4
Stability of Permitted Medications for 4 weeks
Years of education: >= 5
Proficient language fluency
Compliance
Exclusion Criteria:
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:
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).
Facility Information:
Facility Name
Greek Associoation of Alzheimer'S Disease and Related Disorders
City
Thessaloniki
ZIP/Postal Code
54248
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27472878
Citation
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.
Results Reference
result
PubMed Identifier
31802059
Citation
Tzekaki 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.
Results Reference
result
Learn more about this trial
Management of Dementia With Olive Oil Leaves - GOLDEN
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