Clinical trial NCT06819163: Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults
Official title: Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Performance
Keywords: Memory
Attention
Stress
Elderly
Berry leaf extract
Lead sponsor: Seppic
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 106
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Change in spatial working memory performance
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Change in attentional performance
timeFrame: 6 and 12 weeks
measure: Change in psychomotor speed
timeFrame: 6 and 12 weeks
measure: Change in verbal memory performance
timeFrame: 6 and 12 weeks
measure: Change in visual memory performance
timeFrame: 6 and 12 weeks
measure: Change in executive functions' performance
timeFrame: 6 and 12 weeks
measure: Evolution of self-perceived emotional status
timeFrame: 6 and 12 weeks
measure: Evolution of sleep quality
timeFrame: 6 and 12 weeks
measure: Evolution of self-perceived level of stress
timeFrame: 6 and 12 weeks
measure: Evolution of fatigue level
timeFrame: 6 and 12 weeks
measure: Evolution of self-perceived cognitive difficulties
timeFrame: 6 and 12 weeks
measure: Evolution of self-rated general subjective health
timeFrame: 6 and 12 weeks
measure: Evolution of self-perceived enhancement of memory
timeFrame: 6 and 12 weeks
measure: Evolution of self-perceived enhancement of concentration
timeFrame: 6 and 12 weeks
measure: Evolution of self-perceived enhancement of attention
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Louvain-La-Neuve
country: Belgium
facility: Center of Investigation in Clinical Nutrition (CICN)
Study officials:
affiliation: Université Catholique de Louvain
name: Louise Deldicque, Pr
role: STUDY_DIRECTOR
affiliation: Université Catholique de Louvain
name: Sylvie Copine, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Catholique de Louvain
name: Laurent Simar, Dr
role: PRINCIPAL_INVESTIGATOR
References: