Broccoli Sprout Extract for Cognitive Function

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Cognitive Decline; Cognitive Dysfunction

Treatments: Dietary Supplement: Placebo Control; Dietary Supplement: Broccoli sprout extract (BSE)

Study type: Interventional

Funder types: Other

Identifiers

NCT07334366

12-2024-018

Details and patient eligibility

About

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?

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Broccoli group

Experimental group

Description:

This group takes broccoli sporout extract for 12 weeks.

Treatment:

Dietary Supplement: Broccoli sprout extract (BSE)

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 12 weeks.

Treatment:

Dietary Supplement: Placebo Control