Broccoli Sprout Extract for Cognitive Function

Официальное название

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

Обзор

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?

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: 12 weeks]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 1 центр

• Pusan National University Yangsan Hospital — Yangsan

Идентификаторы

NCT: NCT07334366 · 12-2024-018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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