Cognitive PerformanceSLENCT06819163
Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults
A study testing Berry leaf extract in people with Cognitive Performance, run by Seppic at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- Berry leaf extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, 1348
About this study
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
Read the 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
- Being tested
- Berry leaf extract, Placebo
- Keywords
- Memory, Attention, Stress, Elderly, Berry leaf extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Berry leaf extract | Experimental | Dietary supplement - Berry leaf extract Receives: Dietary Supplement: Berry leaf extract |
| Placebo | Placebo comparator | Dietary supplement - Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 and 12 weeks
Secondary outcomes (14)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 and 12 weeks
Evolution of self-perceived emotional status
Comparison between groups of the adjusted for baseline self-perceived level of emotions assessed by the Positive and Negative Affect Schedule (PANAS) questionnaire. Items are rated on a scale ranging from 1 = very slightly or not at all to 5 = extremely.
Measured: 6 and 12 weeks
Evolution of sleep quality
Comparison between groups of the adjusted for baseline sleep quality assessed by the Insomnia Severity Index (ISI) questionnaire. Items are rated on a scale ranging from 0 = no problem to 4 = very severe problem.
Measured: 6 and 12 weeks
Evolution of self-perceived level of stress
Comparison between groups of the adjusted for baseline of self-perceived level of stress assessed by the Perceived Stress Scale (PSS-10) questionnaire. Items are rated on a scale ranging from 0 = never to 4 = very often.
Measured: 6 and 12 weeks
Evolution of fatigue level
Comparison between groups of the adjusted for baseline of level of fatigue assessed by the Fatigue Assessment Scale (FAS) questionnaire. Items are rated on a scale ranging from from 1 = never to 5 = always.
Measured: 6 and 12 weeks
Evolution of self-perceived cognitive difficulties
Comparison between groups of the adjusted for baseline of self-perceived cognitive difficulties assessed by the Cognitive Difficulties Scale (CDS) questionnaire. Items are rated on a scale ranging from 0 = never to 3 = most of the time.
Measured: 6 and 12 weeks
Evolution of self-rated general subjective health
Comparison between groups of the adjusted for baseline of self-rated general subjective health assessed by a visual analogue scale, ranging from 1 = very bad to 5 = very good.
Measured: 6 and 12 weeks
Evolution of self-perceived enhancement of memory
Comparison between groups of the adjusted for baseline of self-perceived enhancement of memory by a visual analogue scale, ranging from 0 = not at all to 4 = very much.
Measured: 6 and 12 weeks
Evolution of self-perceived enhancement of concentration
Comparison between groups of the adjusted for baseline of self-perceived enhancement of concentration assessed by a visual analogue scale, ranging from 0 = not at all to 4 = very much.
Measured: 6 and 12 weeks
Evolution of self-perceived enhancement of attention
Comparison between groups of the adjusted for baseline of self-perceived enhancement of attention assessed by a visual analogue scale, ranging from 0 = not at all to 4 = very much.
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start3 Feb 2025
- Primary completion14 Jul 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seppic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louise Deldicque, Pr, Study director, Université Catholique de LouvainSylvie Copine, Dr, Principal investigator, Université Catholique de LouvainLaurent Simar, Dr, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819163
- Sponsor's protocol ID
- SLE
- Acronym
- SLE
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults
- ClinicalTrials.gov ID
- NCT06819163
- Acronym / sponsor ID
- SLE / SLE
- Conditions
- Cognitive Performance
- Keywords
- Memory, Attention, Stress, Elderly, Berry leaf extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- SeppicIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
| Arm | Type | Receives |
|---|---|---|
| Berry leaf extract | Experimental | Dietary Supplement: Berry leaf extractDietary supplement - Berry leaf extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement - Placebo |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berry leaf extractThe study foresees the intake of 2 capsules per day during 12 weeks | Dietary supplement | Berry leaf extract |
| PlaceboThe study foresees the intake of 2 capsules per day during 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change in spatial working memory performance
Time frame: 6 and 12 weeks
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).
14 secondary outcomes
Change in attentional performance
Time frame: 6 and 12 weeks
Change in psychomotor speed
Time frame: 6 and 12 weeks
Change in verbal memory performance
Time frame: 6 and 12 weeks
Change in visual memory performance
Time frame: 6 and 12 weeks
Change in executive functions' performance
Time frame: 6 and 12 weeks
Evolution of self-perceived emotional status
Time frame: 6 and 12 weeks
Evolution of sleep quality
Time frame: 6 and 12 weeks
Evolution of self-perceived level of stress
Time frame: 6 and 12 weeks
Evolution of fatigue level
Time frame: 6 and 12 weeks
Evolution of self-perceived cognitive difficulties
Time frame: 6 and 12 weeks
Evolution of self-rated general subjective health
Time frame: 6 and 12 weeks
Evolution of self-perceived enhancement of memory
Time frame: 6 and 12 weeks
Evolution of self-perceived enhancement of concentration
Time frame: 6 and 12 weeks
Evolution of self-perceived enhancement of attention
Time frame: 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Deldicque, Pr study director
Université Catholique de Louvain
Sylvie Copine, Dr principal investigator
Université Catholique de Louvain
Laurent Simar, Dr principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry leaf extract in people with Cognitive Performance, run by Seppic at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spatial working memory performance (time frame: 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.