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.

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Eligibility

Primary outcome measure(s)

• 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). — baseline (t0), after 3 months (t1) and after 6 months of treatment (t2).
  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, measured using the Mini-Mental State Examination (MMSE) questionnaire
• 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). — baseline (t0), after 3 months (t1) and after 6 months of treatment (t2).
  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, measured using the Montreal Cognitive Assessment (MoCA) questionnaire

Trial sites (1)

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