<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435509</url>
  </required_header>
  <id_info>
    <org_study_id>31c/17-05-17</org_study_id>
    <nct_id>NCT04435509</nct_id>
  </id_info>
  <brief_title>Management of Mild Cognitive Impairment Patients With Greek Mountain Tea - TEAMENTIA</brief_title>
  <acronym>TEAMENTIA</acronym>
  <official_title>Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Greek Mountain Tea Patiens With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is accumulating evidence suggesting that Greek Mountain Tea may have a positive impact&#xD;
      on conditions involving cognitive deficits, such as Mild Cognitive Impairment (MCI) and AD.&#xD;
      More specifically, greek mountain olympos tee is rich in essential oils, flavonoids,&#xD;
      diterpenes and phenylpropanes, which are primarily responsible for its pharmacological&#xD;
      properties. Its confirmed antioxidant properties are what make mountain tea promising against&#xD;
      Alzheimer's disease and other neurodegenerative diseases. It has also been proven to possess&#xD;
      cholinergic and cognitive enhancing capabilities. Greek Mountain Tea is deeper studied and it&#xD;
      shows promising results in neuroprotection against AD through various suggested mechanisms,&#xD;
      such as the enhancement of amyloid-beta clearance in the brain and the inhibition of&#xD;
      neurofibrillary tangles formation. The aim of the study is to evaluate the beneficial effect&#xD;
      of Greek Mountain Tea in patients diagnosed with mild cognitive impairment MCI.&#xD;
&#xD;
      Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel&#xD;
      Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES OF THE TRIAL&#xD;
&#xD;
      The objectives of this study are:&#xD;
&#xD;
      To investigate the efficacy of Greek Mountain Tea as a disease course modifying treatment for&#xD;
      MCI in a phase III double-blind placebo-controlled study.&#xD;
&#xD;
      To investigate the effects in objective measurements in patients with MCI.&#xD;
&#xD;
      STUDY DESIGN This is a Greek, randomised, double-blind, placebo-controlled study group of&#xD;
      compared Greek Mountain Tea placebo. Qualifying patients will be randomly assigned to receive&#xD;
      12 grams of Greek Mountain Tea or mediterranean dietary protocol on a daily basis for 24&#xD;
      months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning&#xD;
      of the treatment.&#xD;
&#xD;
      Duration The total study duration will be 36 months. Patients will receive study medication&#xD;
      for 24 months.The recruitment will be about 6 months and the statistics and the preparation&#xD;
      of the paper other 6 months. Number of Subjects One hundred fifty (100) subjects total will&#xD;
      be enrolled. ; Fifty (50) in the experimental group (Greek Mountain Tea); and Fifty (50) in&#xD;
      control Group 2(same dietary habits mediterranean dietary protocol).&#xD;
&#xD;
      Patient Eligibility Screening Form (ESF)&#xD;
&#xD;
      An eligibility form documenting the patient's fulfilment of the entry criteria will be&#xD;
      completed by the assessor. The following information will be included in the&#xD;
&#xD;
      ESF:&#xD;
&#xD;
      Patient identification: Initials (First initial of first name and First initial of surname),&#xD;
      date of birth and Patient Identification Number.&#xD;
&#xD;
      Eligibility Screening; Checklist of inclusion and exclusion criteria Eligibility Statement;&#xD;
      for patients found to be ineligible, the reason for ineligibility must be stated Written&#xD;
      informed consent will be obtained from the subject . The informed consent form must be&#xD;
      co-signed by the physician. The nature of the study and the potential risks associated with&#xD;
      the trial will be explained to all subject candidates and their responsible informants.&#xD;
&#xD;
      Signature and date: the ESF may be completed by an assessor but it is required that the&#xD;
      principal investigator/study clinician sign and date the ESF to verify eligibility of the&#xD;
      patient for inclusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 17, 2019</start_date>
  <completion_date type="Anticipated">May 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single (Participant)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single (Participant)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychological Assessment- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Mini-Mental State Examination (MMSE) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FUCAS-Measurements to Assess Daily Functionality</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Functional cognitive assessment scale (FUCAS) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Letter &amp; Category Fluency Test- Measurement to Assess Verbal Fluency and Learning</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Letter &amp; Category Fluency Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CDR- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MoCA- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Montreal Cognitive Assessment (MoCA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CANTAB- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clock Drawing test- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Clock Drawing test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Logical Memory test- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Logical Memory test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Digit Span Forward &amp; Backward test- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Digit Span Forward &amp; Backward test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the WAIS-R Digit Symbol Substitution Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TMT part A and B- Measurements to Assess General Cognitive Function</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Trail Making Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ADASCog-Measurements to Assess Daily Functionality</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Functional Rating Scale for Dementia (FRSSD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Auditory Verbal Learning Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Boston Naming Test- Measurement to Assess Verbal Fluency and Learning</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in the Boston Naming Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NeuroImaging</measure>
    <time_frame>baseline, 12 and 24 months]</time_frame>
    <description>Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSF - beta amyloid</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in mean values on high sensitivity beta-amyloid 1-42 protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSF TAU-protein</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in mean values on TAU-protein in cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electroencephalography recording</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) Electroencephalography recording&#xD;
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</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight in Kilograms</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in weight</description>
  </other_outcome>
  <other_outcome>
    <measure>Height in Meters</measure>
    <time_frame>baseline, 12 and 24 months</time_frame>
    <description>Changes in Height</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Greek Mountain Tea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 patients Greek Mountain Tea 50 grams one per 30 days. Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams Intervention:Greek Mountain Tea in a plastic bag.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mediterranean Diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>50 patients same dietary habits and a Mediterranean dietary protocol Intervention: Mediterranean diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>1000+ Greek Mountain Tea</intervention_name>
    <description>Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams (4 grams 3 times per day ) 50 grams per month</description>
    <arm_group_label>Greek Mountain Tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mediterranean Diet</intervention_name>
    <description>a Mediterranean dietary protocol</description>
    <arm_group_label>Mediterranean Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Memory Complaints&#xD;
&#xD;
          -  Abnormal memory function documented by scoring 1 SD below the ageadjusted mean on the&#xD;
             Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory&#xD;
             Scale-R.&#xD;
&#xD;
          -  MMSE 24-30&#xD;
&#xD;
          -  CDR(sum of boxes) &gt;= 0,5&#xD;
&#xD;
          -  Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)&#xD;
&#xD;
          -  Geriatric Depression Scale (GDS) &lt;6&#xD;
&#xD;
          -  Hachinski Modified Ischemic scale &lt;= 4&#xD;
&#xD;
          -  Stability of Permitted Medications for 4 weeks&#xD;
&#xD;
          -  Years of education: &gt;= 5&#xD;
&#xD;
          -  Proficient language fluency&#xD;
&#xD;
          -  Compliance&#xD;
&#xD;
             -Exclusion Criteria:&#xD;
&#xD;
          -  Antidepressants with anti-cholinergic properties.&#xD;
&#xD;
          -  Regular use of narcotic analgesics (&gt;2 doses per week) within 4 weeks of screening.&#xD;
&#xD;
          -  Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine,&#xD;
             thioridazine) within 4 weeks of screening.&#xD;
&#xD;
          -  Chronic use of other medications with significant central nervous system&#xD;
             anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).&#xD;
&#xD;
          -  Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine,&#xD;
             pergolide, selegeline) within 4 weeks of screening.&#xD;
&#xD;
          -  Participation in any other investigational drug study within 4 weeks of screening&#xD;
             (individuals may not participate in any drug study while participating in this&#xD;
             protocol).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Greek Alzheimer's Association and Related Disorders</name>
      <address>
        <city>Thessaloníki</city>
        <state>Thessaloniki</state>
        <zip>54248</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>27472878</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>31802059</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>October 8, 2019</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Magda Tsolaki</investigator_full_name>
    <investigator_title>MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders</investigator_title>
  </responsible_party>
  <keyword>Mild Cognitive Impairment,</keyword>
  <keyword>Intervention</keyword>
  <keyword>Greek Mountain Tea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435509
org study id: 31c/17-05-17
nct id: NCT04435509
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is accumulating evidence suggesting that Greek Mountain Tea may have a positive impact
      on conditions involving cognitive deficits, such as Mild Cognitive Impairment (MCI) and AD.
      More specifically, greek mountain olympos tee is rich in essential oils, flavonoids,
      diterpenes and phenylpropanes, which are primarily responsible for its pharmacological
      properties. Its confirmed antioxidant properties are what make mountain tea promising against
      Alzheimer's disease and other neurodegenerative diseases. It has also been proven to possess
      cholinergic and cognitive enhancing capabilities. Greek Mountain Tea is deeper studied and it
      shows promising results in neuroprotection against AD through various suggested mechanisms,
      such as the enhancement of amyloid-beta clearance in the brain and the inhibition of
      neurofibrillary tangles formation. The aim of the study is to evaluate the beneficial effect
      of Greek Mountain Tea in patients diagnosed with mild cognitive impairment MCI.

      Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel
      Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
OBJECTIVES OF THE TRIAL

      The objectives of this study are:

      To investigate the efficacy of Greek Mountain Tea as a disease course modifying treatment for
      MCI in a phase III double-blind placebo-controlled study.

      To investigate the effects in objective measurements in patients with MCI.

      STUDY DESIGN This is a Greek, randomised, double-blind, placebo-controlled study group of
      compared Greek Mountain Tea placebo. Qualifying patients will be randomly assigned to receive
      12 grams of Greek Mountain Tea or mediterranean dietary protocol on a daily basis for 24
      months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning
      of the treatment.

      Duration The total study duration will be 36 months. Patients will receive study medication
      for 24 months.The recruitment will be about 6 months and the statistics and the preparation
      of the paper other 6 months. Number of Subjects One hundred fifty (100) subjects total will
      be enrolled. ; Fifty (50) in the experimental group (Greek Mountain Tea); and Fifty (50) in
      control Group 2(same dietary habits mediterranean dietary protocol).

      Patient Eligibility Screening Form (ESF)

      An eligibility form documenting the patient's fulfilment of the entry criteria will be
      completed by the assessor. The following information will be included in the

      ESF:

      Patient identification: Initials (First initial of first name and First initial of surname),
      date of birth and Patient Identification Number.

      Eligibility Screening; Checklist of inclusion and exclusion criteria Eligibility Statement;
      for patients found to be ineligible, the reason for ineligibility must be stated Written
      informed consent will be obtained from the subject . The informed consent form must be
      co-signed by the physician. The nature of the study and the potential risks associated with
      the trial will be explained to all subject candidates and their responsible informants.

      Signature and date: the ESF may be completed by an assessor but it is required that the
      principal investigator/study clinician sign and date the ESF to verify eligibility of the
      patient for inclusion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single (Participant)
primary purpose: Treatment
masking: Single (Participant)
masking description: Single (Participant)
measure: Neuropsychological Assessment- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in Mini-Mental State Examination (MMSE) score
measure: FUCAS-Measurements to Assess Daily Functionality
time frame: baseline, 12 and 24 months
description: Changes in Functional cognitive assessment scale (FUCAS) score
measure: Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
time frame: baseline, 12 and 24 months
description: Changes in the Letter & Category Fluency Test
measure: CDR- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
measure: MoCA- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in Montreal Cognitive Assessment (MoCA)
measure: CANTAB- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
measure: Clock Drawing test- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Clock Drawing test
measure: Logical Memory test- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Logical Memory test
measure: Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Digit Span Forward & Backward test
measure: WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the WAIS-R Digit Symbol Substitution Test
measure: TMT part A and B- Measurements to Assess General Cognitive Function
time frame: baseline, 12 and 24 months
description: Changes in the Trail Making Test
measure: ADASCog-Measurements to Assess Daily Functionality
time frame: baseline, 12 and 24 months
description: Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
measure: Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
time frame: baseline, 12 and 24 months
description: Changes in Functional Rating Scale for Dementia (FRSSD)
measure: Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
time frame: baseline, 12 and 24 months
description: Changes in the Auditory Verbal Learning Test
measure: Boston Naming Test- Measurement to Assess Verbal Fluency and Learning
time frame: baseline, 12 and 24 months
description: Changes in the Boston Naming Test
measure: NeuroImaging
time frame: baseline, 12 and 24 months]
description: Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)
measure: CSF - beta amyloid
time frame: baseline, 12 and 24 months
description: Changes in mean values on high sensitivity beta-amyloid 1-42 protein
measure: CSF TAU-protein
time frame: baseline, 12 and 24 months
description: Changes in mean values on TAU-protein in cerebrospinal fluid
measure: Electroencephalography recording
time frame: baseline, 12 and 24 months
description: Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) 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
measure: Weight in Kilograms
time frame: baseline, 12 and 24 months
description: Changes in weight
measure: Height in Meters
time frame: baseline, 12 and 24 months
description: Changes in Height
arm group label: Greek Mountain Tea
arm group type: Experimental
description: 50 patients Greek Mountain Tea 50 grams one per 30 days. Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams Intervention:Greek Mountain Tea in a plastic bag.
arm group label: Mediterranean Diet
arm group type: Placebo Comparator
description: 50 patients same dietary habits and a Mediterranean dietary protocol Intervention: Mediterranean diet.
intervention type: Dietary Supplement
intervention name: 1000+ Greek Mountain Tea
description: Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams (4 grams 3 times per day ) 50 grams per month
arm group label: Greek Mountain Tea
intervention type: Other
intervention name: Mediterranean Diet
description: a Mediterranean dietary protocol
arm group label: Mediterranean Diet
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Greece
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.
PMID: 27472878
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.
PMID: 31802059
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Magda Tsolaki
investigator title: MD, PhD, Professor, President of Greek Alzheimer's Association and Related Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No