Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial

Обзор

It is known that alcohol consumption can lead to cognitive impairment and dysregulation of inflammatory responses. A preliminary randomized controlled trial conducted by our research team has suggested that nitrate may improve cognition in hospitalized patients with alcohol dependence. To further expand the population and applicability, this study aims to explore the effects of nitrate on cognition in a real-world population of heavy drinkers. The researchers have designed a two-stage clinical trial: the first stage involves the analysis of existing data, and the second stage will recruit 43-54 new participants for a 14-day dietary inorganic nitrate (nitrate-rich beetroot juice, \~750 mg NO3- /d) intervention.

Подробное описание

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Вмешательства

• Пищевая добавка Nitrate-rich beetroot juice
  Nitrate-rich beetroot juice, \~750 mg NO3- /d

Первичные конечные точки

• The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline [Срок оценки: baseline and post-intervention(two weeks after baseline test)]

Вторичные конечные точки (9)

• Changes of Spatial Working Memory Between Errors from baseline to post-intervention [Срок оценки: baseline and post-intervention(two weeks after baseline test)]
• Changes of cognitive function from baseline to post-intervention [Срок оценки: baseline and post-intervention(two weeks after baseline test)]
• Changes of oral microbiota from baseline to post-intervention [Срок оценки: baseline and post-intervention(two weeks after baseline test)]
• Changes of inflammatory factors levels in serum from baseline to post-intervention [Срок оценки: baseline and post-intervention(two weeks after baseline test)]
• depression [Срок оценки: baseline and post-intervention (two weeks after baseline test)]
• anxiety [Срок оценки: baseline and post-intervention(two weeks after baseline test)]
• Sleep Quality [Срок оценки: baseline and post-intervention (two weeks after baseline test)]
• Cognitive [Срок оценки: baseline and post-intervention (two weeks after baseline test)]
• Dream [Срок оценки: baseline and post-intervention (two weeks after baseline test)]

Критерии участия

Критерии включения

A. Individuals with a history of heavy alcohol consumption (as defined below), who have continued heavy drinking within the past week and have no plans to quit drinking within the next month.

B. Individuals with a history of heavy alcohol consumption who are currently hospitalized due to alcohol dependence or alcohol use disorder, and are still undergoing treatment.

The CDC (Centers for Disease Control and Prevention) defines heavy alcohol consumption as follows: For males: more than 15 standard alcoholic drinks per week. For females: more than 8 standard alcoholic drinks per week. Here, one standard drink unit is approximately 14 grams of pure alcohol- C. A Montreal Cognitive Assessment (MoCA) score greater than 13.

Критерии исключения

A. Individuals with a history of or current infectious diseases. B. Individuals with a history of or current severe cardiovascular, cerebrovascular, hepatic, or renal diseases.

C. Individuals who are allergic to any substances used in the trial, such as beets.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06777459 · （2025）PKUh6（3）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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