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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heavy Drinking
• Intervention / Treatment: Dietary supplement: Nitrate-rich beetroot juice

Detailed Description

No comments

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FUYU Song; Phone Number: +8613699266767; Email: songfy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RWS; Interventions:Dietary Supplement: nitrate-rich beetroot juice	Dietary supplement: Nitrate-rich beetroot juice; Nitrate-rich beetroot juice, ~750 mg NO3- /d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of cognitive function from baseline to post-intervention	Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB	baseline and post-intervention(two weeks after baseline test)
Changes of oral microbiota from baseline to post-intervention	Saliva samples were used to test the composition of microbiota by 16S RNA sequencing.	baseline and post-intervention(two weeks after baseline test)
Sleep Quality	Test by pittsburgh sleep quality index	baseline and post-intervention (two weeks after baseline test)
Changes of Spatial Working Memory Between Errors from baseline to post-intervention	Test by SWM-BE (The Spatial Working Memory Between Errors ) The SWM-BE score range is primarily based on the number of errors, typically ranging from 0 to 10 errors. The higher the score, the fewer the errors, and the better the performance.	baseline and post-intervention(two weeks after baseline test)
Changes of inflammatory factors levels in serum from baseline to post-intervention	We collected serum sampleWs were used to test the levels of inflammatory factors by Elisa	baseline and post-intervention(two weeks after baseline test)
depression	Test by Self-Rating Depression Scale	baseline and post-intervention (two weeks after baseline test)
anxiety	Test by Self-Rating Anxiety Scale	baseline and post-intervention(two weeks after baseline test)
Cognitive	Test by Montreal Cognitive Assessment	baseline and post-intervention (two weeks after baseline test)
Dream	Test by Dream Evaluation Scale	baseline and post-intervention (two weeks after baseline test)

Collaborators and Investigators

• Sponsor: Peking University Sixth Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Function; Heavy Drinking; Nitrate; Real World Study; Two-stage adaptive design
• Other Study ID Numbers: （2025）PKUh6（3）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No