Management of Dementia With Olive Oil Leaves - GOLDEN (GOLDEN)

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.

Study Overview

• Status: Unknown
• Conditions: Prevention
• Intervention / Treatment: Other: Beverage of Olive Oil Leaves; Other: Mediterranean Diet

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:

1. 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
2. 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.
3. 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.
4. 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
5. 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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54248
    • Greek Associoation of Alzheimer'S Disease and Related Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beverage of Olive Oil Leaves; 50 patients Beverage of Olive Oil Leaves	Other: Beverage of Olive Oil Leaves; Beverage of Olive Oil Leaves,Oleuropein
Active Comparator: Mediterranean dietary protocol Intervention; 50 patients Dietary Supplement: Dietary Supplement:Mediterranean Diet	Other: Mediterranean Diet; Mediterranean Diet ,for a personal nutrition with the same dietary habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological Assessment - Measurements to Assess General Cognitive Function	Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24	baseline,24 months
FUCAS-Measurements to Assess Daily Functionality	Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42	baseline,24 months
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning	Changes in the Letter & Category Fluency Test	baseline,24 months
CDR- Measurements to Assess General Cognitive Function	Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)	baseline,24 months
MoCA- Measurements to Assess General Cognitive Function	Changes in Montreal Cognitive Assessment (MoCA)	baseline,24 months
Clock Drawing test- Measurements to Assess General Cognitive Function	Changes in the Clock Drawing test	baseline,24 months
Logical Memory test- Measurements to Assess General Cognitive Function	Changes in the Logical Memory test	baseline, 24 months
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function	Changes in the Digit Span Forward & Backward test	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	baseline,24 months
TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function	Changes in the Trail Making Test	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	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	baseline, 24 months
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning	Changes in the Auditory Verbal Learning Test	baseline,24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NeuroImaging	Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)	baseline,24 months
CSF - beta amyloid	Changes in mean values on high sensitivity beta-amyloid 1-42 protein	baseline,24 months
CSF(cerebrospinal fluid) TAU-protein ( soluble protein)	Changes in mean values on TAU-protein in cerebrospinal fluid	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	baseline,24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in Kilograms	Changes in weight	baseline,24 months
Height in Meters	Changes in Height	baseline,24 months

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2019
• Primary Completion (Anticipated): January 10, 2021
• Study Completion (Anticipated): April 10, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Alzheimer's disease; prevention; Mild Dementia; olive oil tree; leaves
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: ID: 46/6-2-19a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No