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

NCT06819163 | Completed

• 1 other identifier: SLE
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Performance

Keywords

Memory; Attention; Stress; Elderly; Berry leaf extract

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Change in attentional performance

  6 and 12 weeks

• Change in psychomotor speed

  6 and 12 weeks

• Change in verbal memory performance

  6 and 12 weeks

• Change in visual memory performance

  6 and 12 weeks

• Change in executive functions' performance

  6 and 12 weeks

Study Arms (2)

Berry leaf extract

EXPERIMENTAL

Dietary supplement - Berry leaf extract

Dietary Supplement: Berry leaf extract

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Berry leaf extract DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 12 weeks

Berry leaf extract

Placebo DIETARY_SUPPLEMENT

The study foresees the intake of 2 capsules per day during 12 weeks

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seppic: lead

Study Sites (1)

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, 1348, Belgium

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 11, 2025
• Study Start: February 3, 2025
• Primary Completion: July 14, 2025
• Study Completion: October 31, 2025
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)