Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Location status: Recruiting
NCT Number: NCT07334366
This clinical trial aims to determine whether broccoli sprout extract improves cognitive function in adults with mild cognitive impairment and to assess its safety.
The main questions are:
* Does broccoli sprout extract improve cognitive function in participants? * What side effects occur when participants take broccoli sprout extract?
Interested in participating?
Request Info50 year–85 year
All sexes
Interventional
Not applicable
Yangsan, 50612, South Korea
Location status: Recruiting
Researchers will compare broccoli sprout extract to a placebo to evaluate their effectiveness in improving cognitive function in participants.
Participants will:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
GDS 2: Subjective memory impairment without objective evidence GDS 3: Mild objective memory impairment
Exclusion criteria
BSE 1,000 mg/day for 12 weeks
Placebo (crystalline cellulosel) 1,000 mg/day for 12 weeks
Time frame: 12 weeks
The change in total CNT score from baseline to 12 weeks, calculated as the sum of verbal learning test, digit span test, and auditory continuous performance test scores. Higher total CNT scores indicate better neurocognitive function across the domains of memory, attention, and sustained concentration. This composite measure assesses overall cognitive performance, where positive changes (increase in total score) indicate cognitive improvement and negative changes (decrease in total score) suggest cognitive decline.
Time frame: 12 weeks
The change in verbal learning test score from baseline to 12 weeks, measuring memory and learning capacity. Higher scores indicate better verbal memory and learning ability. This assessment evaluates the ability to acquire, retain, and recall verbal information over multiple learning trials. Positive changes (increase in score) indicate improvement** in verbal memory function, while negative changes (decrease in score) suggest a decline in verbal learning capacity.
Time frame: 12 weeks
The change in digit span test score from baseline to 12 weeks, measuring working memory and attention span. Higher scores indicate better working memory and attention capacity. This assessment evaluates the ability to temporarily hold and manipulate numerical information in memory through forward and backward digit recall tasks. Positive changes (increase in score) indicate improvement in working memory capacity, while negative changes (decrease in score) suggest decline in attention and short-term memory function.
Time frame: 12 weeks
The change in auditory continuous performance test score from baseline to 12 weeks, measuring sustained attention and concentration abilities. Higher scores indicate better sustained attention and concentration capacity. This assessment evaluates the capacity to maintain focused attention and respond appropriately to auditory stimuli over an extended period. Positive changes (increase in score) indicate improvement in sustained attention function, while negative changes (decrease in score) suggest decline in concentration and vigilance capabilities.
Time frame: 12 weeks
The change in MMSE-K total score from baseline to 12 weeks, providing a brief assessment of global cognitive function. Higher scores indicate better global cognitive function. This standardized instrument evaluates orientation, attention, memory, language, and visuospatial abilities. Positive changes (increase in score) indicate improvement in overall cognitive status, while negative changes (decrease in score) suggest decline in cognitive function.
Time frame: 12 weeks
The change in serum BDNF concentration from baseline to 12 weeks, measured in ng/mL or pg/mL. BDNF is a neurotrophin that plays a crucial role in neuronal survival, growth, and synaptic plasticity. Positive changes indicate increased BDNF levels associated with enhanced neuroplasticity and neuroprotection, while negative changes suggest decreased neurotrophic support.
Time frame: 12 weeks
The change in serum MDA concentration from baseline to 12 weeks, measured in μmol/L or nmol/mL. MDA is a biomarker of lipid peroxidation and oxidative stress, reflecting cellular damage from reactive oxygen species. Positive changes indicate increased oxidative stress and cellular damage, while negative changes stress and improved antioxidant status.
Time frame: 12 weeks
The change in serum SOD activity from baseline to 12 weeks, measured in U/mL or U/mg protein. SOD is a key antioxidant enzyme that catalyzes the dismutation of superoxide radicals, providing cellular protection against oxidative damage. Positive changes indicate enhanced antioxidant capacity and cellular protection, while negative changes suggest reduced antioxidant defense mechanisms.
Contact information is provided by the study sponsor or research team.
Pusan National University Yangsan Hospital
Other
A 12-week Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Broccoli Sprout Extract on Cognitive Function Improvement in Adults With Mild Cognitive Impairment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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