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

NCT ID: NCT06777459

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-12-31

Brief Summary

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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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No comments

Conditions

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Heavy Drinking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RWS

Interventions:Dietary Supplement: nitrate-rich beetroot juice

Group Type EXPERIMENTAL

Nitrate-rich beetroot juice

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nitrate-rich beetroot juice

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Sixth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hongqiang Sun

Vice President of Peking University Sixth Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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FUYU Song

Role: CONTACT

+8613699266767

Other Identifiers

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(2025)PKUh6(3)

Identifier Type: -

Identifier Source: org_study_id

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