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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

None

Trial design

Treatments tested in this trial

  • ACTIVE TREATMENT 1 - OLI-COGNITIVE FOOD SUPPLEMENT
  • ACTIVE TREATMENT 2 - OLI-VERB-COGNITIVE FOOD SUPPLEMENT
  • Placebo

Treatment groups

99 Participants
are divided into 3 treatment groups