Broccoli Sprout Extract for Cognitive Function

Official title

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

Overview

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?

Detailed description

Researchers will compare broccoli sprout extract to a placebo to evaluate their effectiveness in improving cognitive function in participants.

Participants will:

* Take dietary broccoli sprout extract or a placebo daily for 12 weeks. * Visit the clinic at screenig, 0, 6, and 12 weeks for checkups and tests

Interventions

• Dietary supplement Broccoli sprout extract (BSE)
  BSE 1,000 mg/day for 12 weeks
• Dietary supplement Placebo Control
  Placebo (crystalline cellulosel) 1,000 mg/day for 12 weeks

Primary outcome measures

• Change from baseline to 12 weeks in total Computerized NeuroCognitive Function Test score comprising verbal learning test, digit span test, and auditory continuous performance test [Time frame: 12 weeks]

Secondary outcome measures (7)

• Change from baseline to 12 weeks in verbal learning test score [Time frame: 12 weeks]
• Change from baseline to 12 weeks in digit span test score [Time frame: 12 weeks]
• Change from baseline to 12 weeks in auditory continuous performance test score [Time frame: 12 weeks]
• Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score [Time frame: 12 weeks]
• Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration [Time frame: 12 weeks]
• Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration [Time frame: 12 weeks]
• Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• Age: Adults aged 55-85 years (inclusive), both male and female
• Global Deterioration Scale (GDS) score of 2-3:

GDS 2: Subjective memory impairment without objective evidence GDS 3: Mild objective memory impairment

• Absence of dementia according to established diagnostic criteria
• Ability to read Korean

Exclusion criteria

• Severe medical conditions within the past 6 months: History of severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage), cardiac disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignancy (Note: Participants with a history of cerebrovascular or cardiac disease who are clinically stable may be included at the investigator's discretion)
• Cognitive impairment-associated diseases: Dementia, Parkinson's disease, cerebral infarction, or other conditions associated with cognitive decline Uncontrolled hypertension: Blood pressure ≥160/100 mmHg (measured after 10 minutes of rest)
• Poor glycemic control: Fasting blood glucose ≥160 mg/dL in diabetic patients
• Uncontrolled thyroid dysfunction: Currently receiving treatment for uncontrolled hypothyroidism or hyperthyroidism
• Renal impairment: Serum creatinine ≥2 times the upper limit of normal for the institution
• Hepatic impairment: AST or ALT ≥2 times the upper limit of normal for the institution
• Severe gastrointestinal symptoms: Complaints of severe heartburn, dyspepsia, or other gastrointestinal distress
• Medications affecting cognitive function within the past month: Use of drugs (antipsychotics, anti-degenerative agents, cognitive enhancers, tricyclic antidepressants, hormone replacement therapy) or health functional foods that may influence cognitive function due to dementia or other cognitive abnormalities
• Other clinical trial participation: Participation in other drug clinical trials within the past month or planned participation during the study period
• Alcohol use disorder, severe
• Food allergies: Known allergic reactions to study product components
• Investigator discretion: Any other condition deemed inappropriate for study participation by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

South Korea · 1 center

• Pusan National University Yangsan Hospital — Yangsan

Identifiers

NCT: NCT07334366 · 12-2024-018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗