Heavy DrinkingNCT06777459
Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial
A study testing Nitrate-rich beetroot juice in people with Heavy Drinking, run by Peking University Sixth Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Nitrate-rich beetroot juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Individuals with a history of or current infectious diseases. B. Individuals with a history of or current severe cardiovascular, cerebrovascular, hepatic, or renal diseases.
- Individuals who are allergic to any substances used in the trial, such as beets.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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- Conditions
- Heavy Drinking
- Being tested
- Nitrate-rich beetroot juice
- Keywords
- Heavy Drinking, Cognitive Function, Nitrate, Two-stage adaptive design, Real World Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate-rich beetroot juiceDietary supplement
Nitrate-rich beetroot juice, ~750 mg NO3- /d
| Study group | Role | What they receive |
|---|---|---|
| RWS | Experimental | Interventions:Dietary Supplement: nitrate-rich beetroot juice Receives: Dietary Supplement: Nitrate-rich beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and post-intervention(two weeks after baseline test)
Secondary outcomes (9)
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.
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of cognitive function from baseline to post-intervention
Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB
Measured: 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.
Measured: 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
Measured: baseline and post-intervention(two weeks after baseline test)
depression
Test by Self-Rating Depression Scale
Measured: baseline and post-intervention (two weeks after baseline test)
anxiety
Test by Self-Rating Anxiety Scale
Measured: baseline and post-intervention(two weeks after baseline test)
Sleep Quality
Test by pittsburgh sleep quality index
Measured: baseline and post-intervention (two weeks after baseline test)
Cognitive
Test by Montreal Cognitive Assessment
Measured: baseline and post-intervention (two weeks after baseline test)
Dream
Test by Dream Evaluation Scale
Measured: baseline and post-intervention (two weeks after baseline test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqiang Sun, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777459
- Sponsor's protocol ID
- （2025）PKUh6（3）
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial
- ClinicalTrials.gov ID
- NCT06777459
- Acronym / sponsor ID
- （2025）PKUh6（3）
- Conditions
- Heavy Drinking
- Keywords
- Heavy Drinking, Cognitive Function, Nitrate, Two-stage adaptive design, Real World Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
No comments
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RWS | Experimental | Dietary Supplement: Nitrate-rich beetroot juiceInterventions:Dietary Supplement: nitrate-rich beetroot juice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- Individuals with a history of or current infectious diseases. B. Individuals with a history of or current severe cardiovascular, cerebrovascular, hepatic, or renal diseases.
- Individuals who are allergic to any substances used in the trial, such as beets.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate-rich beetroot juiceNitrate-rich beetroot juice, ~750 mg NO3- /d | Dietary supplement | RWS |
Primary outcome
The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline
Time frame: baseline and post-intervention(two weeks after baseline test)
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.
9 secondary outcomes
Changes of Spatial Working Memory Between Errors from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of cognitive function from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of oral microbiota from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of inflammatory factors levels in serum from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
depression
Time frame: baseline and post-intervention (two weeks after baseline test)
anxiety
Time frame: baseline and post-intervention(two weeks after baseline test)
Sleep Quality
Time frame: baseline and post-intervention (two weeks after baseline test)
Cognitive
Time frame: baseline and post-intervention (two weeks after baseline test)
Dream
Time frame: baseline and post-intervention (two weeks after baseline test)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate-rich beetroot juice in people with Heavy Drinking, run by Peking University Sixth Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FUYU Song (+8613699266767, songfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline (time frame: baseline and post-intervention(two weeks after baseline test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.