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

N/ACompletedNCT06819163

Seppic109 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

109

Conditions

Cognitive Performance

Interventions

Berry leaf extractDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, Belgium

Outcomes

Primary Outcomes

Change in spatial working memory performance

Comparison between groups of the adjusted for baseline spatial working memory performance (number of errors) assessed by the Spatial Working Memory (SWM) subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame: 6 and 12 weeks

Secondary Outcomes

Change in attentional performance

Comparison between groups of the adjusted for baseline attentional performance (reaction time) assessed by the Motor Screening Task subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame: 6 and 12 weeks

Change in psychomotor speed

Comparison between groups of the adjusted for baseline psychomotor speed (reaction time) assessed by the Reaction Time (RTI) subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame: 6 and 12 weeks

Change in verbal memory performance

Comparison between groups of the adjusted for baseline verbal memory performance (number of words, number of correct and incorrect responses) assessed by the Verbal Recognition Memory (VRM) subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame: 6 and 12 weeks

Change in visual memory performance

Comparison between groups of the adjusted for baseline visual memory performance (number or errors, number of trials and number of stages completed) assessed by the Paired Associates Learning (PAL) subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame: 6 and 12 weeks

Change in executive functions' performance

Comparison between groups of the adjusted for baseline executive functions performance (number of errors) assessed by the Multitasking Test (MTT) subtest of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Data from ClinicalTrials.gov

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