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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berry leaf extract | Experimental | Dietary supplement - Berry leaf extract |
|
| Placebo | Placebo Comparator | Dietary supplement - Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berry leaf extract | Dietary Supplement | The study foresees the intake of 2 capsules per day during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 and 12 weeks |
| Change in psychomotor speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise Deldicque, Pr | Université Catholique de Louvain | Study Director |
| Sylvie Copine, Dr | Université Catholique de Louvain | Principal Investigator |
| Laurent Simar, Dr | Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Investigation in Clinical Nutrition (CICN) | Louvain-la-Neuve | 1348 | Belgium |
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Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
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| Placebo | Dietary Supplement | The study foresees the intake of 2 capsules per day during 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). |
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 and 12 weeks |