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

NCT06777459 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Heavy Drinking

Interventions

DIETARY_SUPPLEMENT

Nitrate-rich beetroot juice

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

Sponsors & Collaborators

  • Peking University Sixth Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06777459 on ClinicalTrials.gov