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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

ConditionHeavy Drinking
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPeking University Sixth Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Nitrate-rich beetroot juice

    Dietary supplement

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

Treatment groups

43 Participants
are divided into 1 treatment group
Group A: RWSExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
baseline and post-intervention(two weeks after baseline test)
2

Changes of cognitive function from baseline to post-intervention

Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB

Time frame
baseline and post-intervention(two weeks after baseline test)
3

Changes of oral microbiota from baseline to post-intervention

Saliva samples were used to test the composition of microbiota by 16S RNA sequencing.

Time frame
baseline and post-intervention(two weeks after baseline test)
4

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Sixth Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: