Clinical trial NCT06777459: Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial
Official title: Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heavy Drinking
Keywords: Heavy Drinking
Cognitive Function
Nitrate
Two-stage adaptive design
Real World Study
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: No comments

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline
timeFrame: baseline and post-intervention(two weeks after baseline test)
Secondary outcomes:
measure: Changes of Spatial Working Memory Between Errors from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of cognitive function from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of oral microbiota from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of inflammatory factors levels in serum from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: depression
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: anxiety
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Sleep Quality
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: Cognitive
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: Dream
timeFrame: baseline and post-intervention (two weeks after baseline test)
Other outcomes:
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