Effects of berry leaf extract on cognitive performance in older adults
Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults
This study is testing whether a berry leaf supplement can help older adults with memory problems improve their thinking and manage stress better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Seppic Industry-sponsored |
| Locations | 1 site (Louvain-La-Neuve) |
| Trial ID | NCT06819163 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a dietary supplement made from berry leaf extract on cognitive performance and stress regulation in healthy elderly adults who report memory issues. It is a randomized double-blind placebo-controlled trial involving 106 participants aged 60 to 80. Over 12 weeks, participants will receive either the active supplement or a placebo, with cognitive and psychological assessments conducted at baseline, 6 weeks, and 12 weeks to measure changes in memory, attention, mood, and fatigue.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 60 to 80 with self-reported memory complaints and a BMI between 18 and 30.
Not a fit: Patients with severe medical or cognitive issues or those with a MMSE score of 24 or lower may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function and overall well-being in elderly individuals experiencing memory complaints.
How similar studies have performed: While the specific use of berry leaf extract is novel, similar studies on dietary supplements for cognitive enhancement in the elderly have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louvain-La-Neuve
- Center of Investigation in Clinical Nutrition (CICN) — Louvain-La-Neuve, Belgium (Recruiting)
Study contacts
- Principal investigator: Sylvie Copine, Dr — Université Catholique de Louvain
- Study coordinator: Valérie Dormal, PhD
- Email: valerie.dormal@uclouvain.be
- Phone: +32(0)10 47 93 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.