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

NCT06777459 | Not Yet Recruiting

• 1 other identifier: （2025）PKUh6（3）
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heavy Drinking

Keywords

Heavy Drinking; Cognitive Function; Nitrate; Two-stage adaptive design; Real World Study

Outcome Measures

Primary Outcomes (1)

• The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline

  Test by DMS-PCAD (Delayed Match to Sample Percent Correct , all delays) The score range is from 0% to 100%, with higher scores indicating better performance in visual memory and matching tasks.

  baseline and post-intervention(two weeks after baseline test)

Secondary Outcomes (9)

• Changes of Spatial Working Memory Between Errors from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of cognitive function from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of oral microbiota from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of inflammatory factors levels in serum from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• depression

  baseline and post-intervention (two weeks after baseline test)

Study Arms (1)

RWS

EXPERIMENTAL

Interventions:Dietary Supplement: nitrate-rich beetroot juice

Dietary Supplement: Nitrate-rich beetroot juice

Interventions

Nitrate-rich beetroot juice DIETARY_SUPPLEMENT

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

RWS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Central Study Contacts

FUYU Song

CONTACT

+8613699266767; songfy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Sixth Hospital

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share