Effects of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Diet Adherence on the Cognitive Health of Patients With Mild Cognitive Impairment (MEDIPHENO-HT)
28 de junho de 2026 atualizado por: Panhellenic Federation of Alzheimer's Disease and Related Disorders
Hydroxytyrosol-Rich Olive Juice Polyphenol and Mediterranean Diet (The MEDIPHENO-HTrial) in Prevention of Cognitive Decline in Community-Dwelling Patients With Mild Cognitive Impairment: A Double-Blind, Placebo-Controlled, 3-Arm, Randomised Controlled Clinical Study
Nutrition is an important modifiable risk factor of human cognitive health.
Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life.
In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline.
The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
141
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Magda Tsolaki, Professor Emeritus, MD, PhD
- Número de telefone: +30 2310316143
- E-mail: tsolakim1@gmail.com
Locais de estudo
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Central Macedonia
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Thessaloniki, Central Macedonia, Grécia, 54250
- Recrutamento
- Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 54250, Greece.
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Contato:
- Magda Tsolaki, Professor Emeritus, MD, PhD
- Número de telefone: +30 2310316143
- E-mail: tsolakim1@gmail.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- GR-based men and women aged 50 - 85
- Willingness and ability to conform to the full protocol.
- Ability to accept and sign the consent form.
- Presence of a diagnostic classification of Mild Cognitive Impairment according to the National Institute on Aging and Alzheimer's Association (NIA-AA) framework MCI, which corresponds to stage 3 on the pre-dementia range.
- MoCA score of ≥18 and ≤ 26. Or
- MMSE (Mini-Mental State Examination) score of ≥26 and ≤ 28.
- No active suicide ideation based on the Columbia-Suicide Severity Rating Scale.
- Absence of severe depressive symptomatology based on the Geriatric Depression Scale-15.
- Not using any laxative drugs for at least three days prior to the screening visit.
- Information about APOE status
Exclusion Criteria:
- Patients with mild, moderate, or severe dementia.
- Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
- Any known issues with blood taking.
- Any known bleeding disorders.
- Any known allergy to olives, inability to tolerate gluten or multiple allergies/intolerances that would significantly limit food intake.
- Average alcohol use of >21 glasses per week for men and >14 glasses per week for women (on average for the last six months).
- History of psychiatric illness including intellectual disability, schizophrenia, bipolar disorder, severe, active depression and alcoholism.
- Neurologic conditions such as vascular dementia, movement disorders, history of conditions such as anaemia and cancer in the last five years, renal or liver failure, malignant tumours, or organ transplant.
- Coffee consumption greater than 5 cups per day.
- Body mass index > 35 kg/ m2.
- Not taking a stable dose of statins for at least 3 months before the recruitment visit. Taking antibiotics in the 1 week preceding the recruitment visit.
- Pregnancy or lactation.
- Participation in another clinical trial during the last 30 days prior to the recruitment visit.
- Subject taking supplements that may affect lipoprotein metabolism, >1 g of fish oil/day, antioxidant supplements, cannabidiol (CBD) oil.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Active Arm - Low Dose
Low dose: 8 drops (20mg of polyphenols) + Mediterranean Diet instructions
|
This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial.
The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies.
Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo.
The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
|
|
Experimental: Experimental Arm - High Dose
High dose: 16 drops (40mg of polyphenols) + Mediterranean Diet instructions
|
This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial.
The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies.
Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo.
The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
|
|
Comparador de Placebo: Placebo Comparator Arm
Placebo 8 drops + Mediterranean Diet instructions
|
This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial.
The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies.
Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo.
The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by ADAS-Cog.
ADAS-Cog ranges from 0-85 by summing the number of errors made on each task, so that higher scores indicate worse performance.
|
From baseline to Week 52
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Key secondary: Mean change on the Montreal Cognitive Assessment Test (MoCA) total score from baseline to Week 52 compared with placebo
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by MoCA.
The total possible score for the test is 30 points by summing the number of correct responses given in each task, so higher scores indicate better performance.
|
From baseline to Week 52
|
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- Mean change on Clinical Dementia Rating - Sum of boxes (CDR-SB) from baseline to Week 52 compared with placebo
Prazo: From baseline to Week 52
|
- The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the CDR-SB, which ranges from 0 to 18, and is calculated by summing the ratings across each of the six domains (memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care), with higher scores indicating greater impairment.
|
From baseline to Week 52
|
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Mean change on Mini-Mental State Examination (MMSE) from baseline to Week 52 compared with placebo
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the MMSE, which is a 30-point brief screening measure of cognitive status.
Higher scores indicate better performance.
|
From baseline to Week 52
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- Mean change on Geriatric Depression Scale-15 (GDS-15) from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
- The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on GDS-15, which consists of 15 items and is used to screen for depression in adults.
GDS-15 assess mental health based on feelings over the past week, with higher scores on the measure denoting more severe levels of depressive symptoms.
|
From baseline to Week 52
|
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- Mean change on Short Anxiety Screening Test (SAST-10) from baseline to Week 52 compared with placebo
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on SAST-10, which is a brief questionnaire designed to assess anxiety.
SAST-10 scores range from 10 to 40, with higher scores on the measure denoting more severe levels of anxiety symptoms.
|
From baseline to Week 52
|
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- Mean change on Functional Rating Scale of Symptoms of Dementia (FRSSD) from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on FRSSD.
The scale ranges from 0 (fully independent) to 42 (fully dependent), with lower scores indicating better daily functioning.
|
From baseline to Week 52
|
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- Mean change on Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-MCI-ADL) from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52.
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on ADCS-MCI-ADL, which is a brief questionnaire designed to capture functional abilities (with recall "In the past 4 weeks").
The 18-item ADCS-ADL-MCI is scored from 0 to 53 based on the subject's degree of independence in performing specific tasks.
Lower scores on the measure denote more substantial impairment.
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From baseline to Week 52.
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- Mean change on Quality of life in Alzheimer's disease (QoL-AD) from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52.
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on QoL-AD, which is a brief 13-item questionnaire designed to assess quality of life.
QoL-AD range from 13 to 52, with higher scores indicating better quality of life.
|
From baseline to Week 52.
|
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- Mean change on - Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52.
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on PSQI, which is a questionnaire designed to assess Sleep quality.
PSQI range from 0 to 21, with higher scores indicating poor sleep.
|
From baseline to Week 52.
|
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- Mean change in LDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on LDL-C mg/dL cholesterol.
|
From baseline to Week 52
|
|
- Mean change in HDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on HDL-C mg/dL cholesterol.
|
From baseline to Week 52
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean percentage change in plasma phosphorylated tau 217 (p-tau217) pg/mL from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
Exploratory analyses will include blood biomarkers, p-tau217 pg/mL.
Mean percentage change in plasma p-tau217 pg/mL from baseline to Week 52 compared with placebo.
|
From baseline to Week 52
|
|
Mean percentage change in plasma levels of beta-amyloid 1-42 (Aβ 1-42) pg/mL from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
Exploratory analyses will include blood biomarkers, Aβ 1-42 pg/mL.
Mean percentage change in plasma levels of Aβ 1-42 pg/mL from baseline to Week 52 compared with placebo.
|
From baseline to Week 52
|
|
Mean percentage change in plasma Glial Fibrillary Acidic Protein (GFAP) pg/mL concentration from baseline to Week 52 compared with placebo.
Prazo: From baseline to Week 52
|
Exploratory analyses will include blood biomarkers, GFAP pg/mL.
Mean percentage change in plasma GFAP pg/mL concentration from baseline to Week 52 compared with placebo.
|
From baseline to Week 52
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Investigadores
- Investigador principal: Vilma Chalili, School of Medicine, Aristotle University of Thessaloniki
- Cadeira de estudo: Magda Tsolaki, First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
31 de março de 2025
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
17 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de junho de 2026
Primeira postagem (Real)
29 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 107/12-3-2025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .