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Not yet recruiting NCT06777459

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

No phase Interventional Heavy Drinking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitrate-rich beetroot juice.
Who it may be relevant to
Registry conditions: Heavy Drinking. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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Interventions

  • Dietary supplement Nitrate-rich beetroot juice
    Nitrate-rich beetroot juice, \~750 mg NO3- /d

Primary outcome measures

  • The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline [Time frame: baseline and post-intervention(two weeks after baseline test)]
Secondary outcome measures (9)
  • Changes of Spatial Working Memory Between Errors from baseline to post-intervention [Time frame: baseline and post-intervention(two weeks after baseline test)]
  • Changes of cognitive function from baseline to post-intervention [Time frame: baseline and post-intervention(two weeks after baseline test)]
  • Changes of oral microbiota from baseline to post-intervention [Time frame: baseline and post-intervention(two weeks after baseline test)]
  • Changes of inflammatory factors levels in serum from baseline to post-intervention [Time frame: baseline and post-intervention(two weeks after baseline test)]
  • depression [Time frame: baseline and post-intervention (two weeks after baseline test)]
  • anxiety [Time frame: baseline and post-intervention(two weeks after baseline test)]
  • Sleep Quality [Time frame: baseline and post-intervention (two weeks after baseline test)]
  • Cognitive [Time frame: baseline and post-intervention (two weeks after baseline test)]
  • Dream [Time frame: baseline and post-intervention (two weeks after baseline test)]

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.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06777459 · （2025）PKUh6（3）

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗