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

Launched by SEPPIC · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether a dietary supplement made from berry leaf extract can help improve thinking skills and manage stress, mood, sleep, and fatigue in healthy older adults who feel they have memory problems. The study is currently looking for participants aged 60 to 80 years who have experienced some memory issues but are otherwise healthy. To join, individuals need to have completed at least 12 years of formal education and meet certain health criteria, such as having a body mass index (BMI) between 18 and 30.

Participants in this trial can expect to take the berry leaf extract supplement and be involved in various assessments to evaluate changes in their cognitive performance over time. They will need to commit to maintaining their usual lifestyle, including diet and exercise, during the study. It's important to note that some individuals, such as those with severe health issues, those who smoke, or those on certain medications, may not be eligible to participate. This study aims to provide insights into how natural supplements might benefit cognitive health in older adults, so if you meet the criteria and are interested, consider reaching out to learn more!

Gender

ALL

Eligibility 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