Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults

NCT ID: NCT06819163

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-10-31

Brief Summary

This study aims to explore the positive effect of a dietary supplement composed of berry leaf extract on the cognitive performance and regulation of stress, mood, sleep and fatigue in healthy elderly adults with self-reported memory complaints

Detailed Description

This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and six participants (aged between 60 and 80), with self-perceived memory complaints, will be randomly allocated to the control (placebo supplement) or test (active supplement) group. Participants will be supplemented during 12 weeks with those products. Cognitive performance and psychological and emotional processing will be measured with tests and questionnaires before (baseline), at the middle (6 weeks), and at the end (12 weeks) of the intervention.

Conditions

Cognitive Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Berry leaf extract

Dietary supplement - Berry leaf extract

Group Type: EXPERIMENTAL

Berry leaf extract

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 12 weeks

Placebo

Dietary supplement - Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 12 weeks

Interventions

Berry leaf extract

The study foresees the intake of 2 capsules per day during 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The study foresees the intake of 2 capsules per day during 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy woman or man
• Aged of 60 to 80 years (inclusive)
• With self-perceived memory complaints (CDS score ≥ 15)
• With a Body Mass Index (BMI) comprised between 18 and 30 kg/m2 (included)
• Participants must have completed a minimum of 12 years of formal education, starting from the age of 6. This corresponds to an education level equivalent to the completion of secondary school (e.g., a high school diploma or equivalent)
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Stated willingness to maintain their usual life habits (diet, physical activity, alcohol consumption…)
• Speaking French

Exclusion Criteria

• Subject with severe medical or cognitive problems which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety
• Subject with a MMSE score ≤ 24
• Subject with a coffee consumption of more than 5 cups per day
• Subject consuming drugs and/or with historical drug addiction (<5 years)
• Subject with a regular alcohol consumption exceeding 3 standard drinks per day (10 g of pure alcohol each), equivalent to 3 glasses of wine (12 cl), 3 glasses of beer (5°, 25cl), or 3 glasses of spirits (18°, 7 cl)
• Smoker or subject consuming regularly products containing nicotine
• Subject following a vegetarian or vegan diet
• Subject with known hypersensitivity to any component of the study product
• Subject who has taken in the 28 days preceding the screening visit or is currently taking drugs or food supplements aiming at improving memory, concentration, sleep, stress, anxiety or other substances which could, in the opinion of the Principal Investigator, interfere with cognitive and emotional processing
• Subject participating in another intervention trial

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seppic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Deldicque, Pr

Role: STUDY_DIRECTOR

Université Catholique de Louvain

Sylvie Copine, Dr

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Laurent Simar, Dr

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

SLE

Identifier Type: -

Identifier Source: org_study_id