Study on the Effectiveness and Safety of Two Olive Extract- Based (Olea Europea L. Folium) Supple… (NCT07586410) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Effectiveness and Safety of Two Olive Extract- Based (Olea Europea L. Folium) Supplements, Alone or Combined With a Mullein Extract (Verbascum Thapsus L. Herba Cum Floribus), for the Maintenance of Cognitive Function.
Italy99 participantsStarted 2026-05-05
Plain-language summary
The goal of this clinical trial is to learn if two food supplements based on olive leaf extract, alone or combined with mullein extract, help maintain cognitive function in older adults with mild cognitive impairment (MCI). It will also evaluate their safety. The main questions it aims to answer are:
Do the supplements improve or help maintain cognitive function (such as memory and attention)? Do participants experience any side effects when taking the supplements?
Researchers will compare two active supplements to a placebo (a look-alike substance with no active ingredients) to see if the supplements are effective.
Participants will:
Take either one of the two supplements or a placebo every day for 6 months Take 2 capsules per day, preferably between meals, with a small amount of water Visit the clinic at the start of the study, after 3 months, and after 6 months for cognitive assessments Complete questionnaires to evaluate cognitive function and quality of life Be monitored throughout the study for any side effects
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participants of both sexes who meet the following characteristics will be included in the study:
* aged between 60 and 85 years;
* able to understand and sign the informed consent form;
* able to understand and comply with the protocol requirements;
* negative HIV test;
* score between 20 and 25 on the Montreal Cognitive Assessment (MoCA) questionnaire (Nasreddine et al., 2005).
* total Instrumental Activities of Daily Living (IADL) + Activities of Daily Living (ADL) score of 14;
* Geriatric Depression Scale (GDS) score between 0 and 5;
* Generalized Anxiety Disorder (GAD-7) score between 0 and 4;
* not currently taking or taking any medications, including antidiabetics, drugs that affect the nervous system such as antidepressants, anxiolytics, or opioids;
* who are not taking antibiotics or have not taken antibiotics in the last four weeks, or in the last 6 months, based on the intensity and duration of antibiotic treatment.
Subjects with the following characteristics will be excluded from the study:
* aged \< 60 and \> 85 years;
* individuals with a MoCA questionnaire score \< 20 and \> 26;
* Geriatric Depression Scale (GDS) score \> 5;
* Generalized Anxiety Disorder (GAD-7) score \> 4;
* who show no willingness to cooperate;
* who have difficulty traveling to the referral facility on time;
* who are deemed unsuitable by the investigator due to the presence of other conditions deemed incompatible with enrollment and which require pharmacological treatments (e.g., active …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome of the study is to evaluate the effect of supplementation with the two active treatments based on plant extracts on cognitive functions using the Mini-Mental State Examination (MMSE).
Timeframe: baseline (t0), after 3 months (t1) and after 6 months of treatment (t2).
2
The primary outcome of the study is to evaluate the effect of supplementation with the two active treatments based on plant extracts on cognitive functions using Montreal Cognitive Assessment (MoCA).
Timeframe: baseline (t0), after 3 months (t1) and after 6 months of treatment (t2).