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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.

NCT07586410 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-05-14

No results posted yet for this study

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

Conditions

  • Cognition Disorders in Old Age

Interventions

DIETARY_SUPPLEMENT

ACTIVE TREATMENT 1 - OLI-COGNITIVE FOOD SUPPLEMENT

INGREDIENTS: Olea europea L. - folium extract, dry extract standardized to contain 12% oleuropein; glazing agent: hydroxypropyl methylcellulose (E464); anti-caking agent: magnesium salts of fatty acids (E470b); coloring agent: iron oxides and hydroxides (E172). Directions for use: Take 2 capsules daily (containing a total of 600 mg of Olea europea dry extract - 72 mg of oleuropein), preferably between meals, with a small amount of water.

DIETARY_SUPPLEMENT

ACTIVE TREATMENT 2 - OLI-VERB-COGNITIVE FOOD SUPPLEMENT

INGREDIENTS: Olea europea L. - folium extract, dry extract titrated at 12% in oleuropein; Verbascum thapsus L. - herba cum floribus leaf extract, dry extract titrated at 3% in verbascoside; glazing agent: hydroxypropyl methylcellulose (E464); anti-caking agent: magnesium salts of fatty acids (E470b); colouring agent: iron oxides and hydroxides (E172).

OTHER

Placebo

The placebo consists of inert excipients and is identical in shape, color, odor, taste, weight, and packaging to the active treatment, thus ensuring blinding.

Sponsors & Collaborators

  • ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07586410 on ClinicalTrials.gov