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Completed

NCT Number: NCT06819163

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

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

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Key information

Conditions

Cognitive Performance

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, 1348, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berry leaf extract

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in attentional performance

    Time frame: 6 and 12 weeks

    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).

  2. Change in psychomotor speed

    Time frame: 6 and 12 weeks

    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).

  3. Change in verbal memory performance

    Time frame: 6 and 12 weeks

    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).

  4. Change in visual memory performance

    Time frame: 6 and 12 weeks

    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).

  5. Change in executive functions' performance

    Time frame: 6 and 12 weeks

    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).

  6. Evolution of self-perceived emotional status

    Time frame: 6 and 12 weeks

    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.

  7. Evolution of sleep quality

    Time frame: 6 and 12 weeks

    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.

  8. Evolution of self-perceived level of stress

    Time frame: 6 and 12 weeks

    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.

  9. Evolution of fatigue level

    Time frame: 6 and 12 weeks

    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.

  10. Evolution of self-perceived cognitive difficulties

    Time frame: 6 and 12 weeks

    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.

  11. Evolution of self-rated general subjective health

    Time frame: 6 and 12 weeks

    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.

  12. Evolution of self-perceived enhancement of memory

    Time frame: 6 and 12 weeks

    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.

  13. Evolution of self-perceived enhancement of concentration

    Time frame: 6 and 12 weeks

    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.

  14. Evolution of self-perceived enhancement of attention

    Time frame: 6 and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Seppic

Industry

Registry information

Acronym: SLE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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