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

Seppic

Status: Completed

Conditions: Cognitive Performance

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Berry leaf extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT06819163

SLE

Details and patient eligibility

About

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

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups, including a placebo group

Berry leaf extract

Experimental group

Description:

Dietary supplement - Berry leaf extract

Treatment:

Dietary Supplement: Berry leaf extract

Placebo

Placebo Comparator group

Description:

Dietary supplement - Placebo

Treatment:

Dietary Supplement: Placebo