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 | Not Yet Recruiting

• 1 other identifier: OLI-VERB-COGNITIVE26
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cognitive decline; elderly people; food supplement; congitive function; preventivon

Outcome Measures

Primary Outcomes (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 the Mini-Mental State Examination (MMSE).

  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

  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 using Montreal Cognitive Assessment (MoCA).

  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

  baseline (t0), after 3 months (t1) and after 6 months of treatment (t2).

Secondary Outcomes (1)

• The design of the proposed study assumes as a secondary outcome the evaluation of the efficacy of the two food supplements in improving the perception of general quality of life (physical and mental component)

  baseline (t0) and after 6 months of treatment (t2).

Study Arms (3)

GROUP 1: subjects who will take the dietary supplement based on olive leaf extract

EXPERIMENTAL

GROUP 1 (22 subjects) subjects who will have to take the food supplement based on olive leaf extract (Olea europea L.)

Dietary Supplement: ACTIVE TREATMENT 1 - OLI-COGNITIVE FOOD SUPPLEMENT

subjects who will take the food supplement based on olive extract and mullein extract

EXPERIMENTAL

GROUP 2 (22 subjects) subjects who will have to take the food supplement based on olive extract (Olea europea L. folium) and mullein extract (Verbascum thapsus L. herba cum floribus).

Dietary Supplement: ACTIVE TREATMENT 2 - OLI-VERB-COGNITIVE FOOD SUPPLEMENT

PLACEBO

PLACEBO COMPARATOR

GROUP 3 subjects who will take placebo

Other: Placebo

Interventions

ACTIVE TREATMENT 1 - OLI-COGNITIVE FOOD SUPPLEMENT DIETARY_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.

GROUP 1: subjects who will take the dietary supplement based on olive leaf extract

ACTIVE TREATMENT 2 - OLI-VERB-COGNITIVE FOOD SUPPLEMENT DIETARY_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).

subjects who will take the food supplement based on olive extract and mullein extract

Placebo OTHER

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

PLACEBO

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 systemic diseases, diabetes, neurological and psychiatric conditions, including cognitive disorders that prevent completion of the questionnaires); * affected by HIV-acquired immunodeficiency; * individuals with severe visual and hearing impairments; * with known allergies to ingredients of the investigational products (active or placebo); * who abuse alcohol, drugs, nicotine, caffeine, or theine; * who take medications.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL: lead

Study Sites (1)

COMEGEN Soc. Coop. Sociale, Napoli, 80126

Naples, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Alessandra A Baldi, graduated

CONTACT

+393483854114; alessandra.baldi.alimenti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, placebo-controlled, parallel-arm, double-blind clinical trial.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 14, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)