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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.
Sponsor: ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL
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
Official title: Efficacy and Tolerability Study of Two Food Supplements, the First Based on an Olive Extract (Olea Europea L. Folium) and the Second on the Combination of the Latter With a Mullein Extract (Verbascum Thapsus L. Herba Cum Floribus), for the Maintenance of Cognitive Function: a Single-center, Randomized, Placebo-controlled, Parallel-arm, Double-blind Clinical Study.
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2026-05-05
Completion Date
2026-11
Last Updated
2026-05-14
Healthy Volunteers
Yes
Conditions
Interventions
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.
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).
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.
Locations (1)
COMEGEN Soc. Coop. Sociale, Napoli, 80126
Naples, Italy