MicrotiaNCT05963659
Nitrate Modulates Cognitive Impairment Via Oral Microbiota.
A study testing nitrate-rich beetroot juice and nitrate-depleted beetroot juice in people with Microtia and Alcohol Dependence, run by Peking University Sixth Hospital at 1 site in China.
Trial summary
Alcohol use is increasingly prevalent in modern society and is known to cause cognitive impairment and dysregulation of inflammatory responses. In the present study, the investigators want to perform a randomised controlled trials to test whether nitrate could change the oral microbiota and benefit the cognitive… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Microtia, Alcohol Dependence
- What is being tested?
- nitrate-rich beetroot juice and nitrate-depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 7 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Han nationality
- Montreal Cognitive Assessment(MoCA) score >11
- Diagnosis of alcohol dependence
Who cannot join
- Past or current infectious disease
- Past or current heart, brain, liver, kidney, and other severe diseases
- Past or current metabolic diseases that can lead to abnormalities of the immune system, such as obesity (Body Mass Index > 30 kg/m2), diabetes, or rheumatoid arthritis
- Past or current neurodegenerative diseases, such as Parkinson's disease
- Use of steroidal and non-steroidal anti-inflammatory drugs, antibiotics, antioxidants, and immunosuppressive agents within two months of enrollment
- Use of probiotics and probiotics every day for the first two months before enrollment
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- Previous or current DSM-IV diagnosis of schizophrenia, depression, anxiety disorder, bipolar disorder, mental retardation, dementia (excluding mild cognitive impairment, MCI), or substance dependence other than alcohol and nicotine
- Irregular eating habits that affect the oral flora (except alcohol) in the previous two months
- Current oral disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nitrate on Cognitive Function in Alcohol Dependence Patients and the Potential Microbiota Mechanism.
Alcohol use is increasingly prevalent in modern society and is known to cause cognitive impairment and dysregulation of inflammatory responses. In the present study, the investigators want to perform a randomised controlled trials to test whether nitrate could change the oral microbiota and benefit the cognitive impairment in alcohol dependence patients. The investigators survey the oral bacterial communities in saliva samples of 70 alcohol dependent patients following 14 days of dietary inorganic nitrate (nitrate-rich beetroot juice, ~750 mg NO3- /d) and placebo (nitrate-depleted beetroot juice, ~1 mg NO3- /d) supplementation.
- Conditions
- Microtia, Alcohol Dependence
- Being tested
- nitrate-rich beetroot juice, nitrate-depleted beetroot juice
- Keywords
- nitrate, oral microbiota, alcohol dependence
- Medical subject headings
- Congenital Microtia, Alcoholism
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
nitrate-depleted beetroot juiceDietary supplement
nitrate-depleted beetroot juice, ~1 mg NO3- /d
| Study group | Role | What they receive |
|---|---|---|
| Group N | Experimental | Not described Receives: Dietary Supplement: nitrate-rich beetroot juice |
| Group P | Placebo comparator | Not described Receives: Dietary Supplement: nitrate-depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Delayed Match to Sample Percent Correct (all delays) from baseline to post-intervention
Test by DMS-PCAD (Delayed Match to Sample Percent Correct , all delays)
Measured: 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 )
Measured: baseline and post-intervention(two weeks after baseline test)
Secondary outcomes (20)
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 gut microbiota from baseline to post-intervention
Feces 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 Delayed Match to Sample Percent Correct (0 seconds delay) from baseline to post-intervention
Test by Delayed Match to Sample Percent Correct (0 seconds delay)
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Delayed Match to Sample Percent Correct (4 seconds delay) from baseline to post-intervention
Test by Delayed Match to Sample Percent Correct (4 seconds delay)
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Delayed Match to Sample Percent Correct (12 seconds delay) from baseline to post-intervention
Test by Delayed Match to Sample Percent Correct (12 seconds delay)
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Spatial Working Memory errors 4 boxes from baseline to post-intervention
Test by The Spatial Working Memory errors 4 boxes
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Spatial Working Memory errors 6 boxes from baseline to post-intervention
Test by The Spatial Working Memory errors 6 boxes
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Spatial Working Memory errors 8 boxes from baseline to post-intervention
Test by The Spatial Working Memory errors 8 boxes
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Intra-Extra Dimensional Set Shift test Stages Completed from baseline to post-intervention
Test by The Intra-Extra Dimensional Set Shift test Stages Completed
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Intra-Extra Dimensional Completed Stage Errors from baseline to post-intervention
Test by The Intra-Extra Dimensional Completed Stage Errors
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment from baseline to post-intervention
Test by Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Cambridge Gambling Decision Making Quality Total Merged from baseline to post-intervention
Test by Cambridge Gambling Decision Making Quality Total Merged
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Cambridge Gambling Delay Aversion Total from baseline to post-intervention
Test by Cambridge Gambling Delay Aversion Total
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Reaction Time Median Five-Choice Movement Time from baseline to post-intervention
Test by Reaction Time Median Five-Choice Movement Time
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Reaction Time Median Five-Choice Reaction Time from baseline to post-intervention
Test by Reaction Time Median Five-Choice Reaction Time
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Rapid Visual Information Processing test Probability of False Alarm from baseline to post-intervention
Test by the Rapid Visual Information Processing test Probability of False Alarm
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Rapid Visual Information Processing test A prime from baseline to post-intervention
Test by the Rapid Visual Information Processing test A prime
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of Rapid Visual Information Processing test Median Response Latency from baseline to post-intervention
Test by the Rapid Visual Information Processing test Median Response Latency
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of nitrate levels in serum from baseline to post-intervention
The collected serum samples were used to test the levels of nitrate and nitrite by High Performance Liquid Chromatography \ HPLC
Measured: baseline and post-intervention(two weeks after baseline test)
Changes of nitrite levels in serum from baseline to post-intervention
The collected serum samples were used to test the levels of nitrate and nitrite by High Performance Liquid Chromatography \ HPLC
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 posted27 Jul 2023
- Study start10 Sep 2023
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrotiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
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
- Investigators
- Hongqiang Sun, Principal investigator, Peking University Sixth HospitalLiangjun Pang, Study chair, Anhui mental health central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963659
- Sponsor's protocol ID
- 20230630
- Status last verified
- May 2025
- First submitted
- 30 Jun 2023
- Last updated
- 3 Jun 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitrate on Cognitive Function in Alcohol Dependence Patients and the Potential Microbiota Mechanism.
- ClinicalTrials.gov ID
- NCT05963659
- Acronym / sponsor ID
- 20230630
- Conditions
- Microtia, Alcohol Dependence
- Keywords
- nitrate, oral microbiota, alcohol dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 27 Jul 2023 (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.
Alcohol use is increasingly prevalent in modern society and is known to cause cognitive impairment and dysregulation of inflammatory responses. In the present study, the investigators want to perform a randomised controlled trials to test whether nitrate could change the oral microbiota and benefit the cognitive impairment in alcohol dependence patients. The investigators survey the oral bacterial communities in saliva samples of 70 alcohol dependent patients following 14 days of dietary inorganic nitrate (nitrate-rich beetroot juice, ~750 mg NO3- /d) and placebo (nitrate-depleted beetroot juice, ~1 mg NO3- /d) supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N | Experimental | Dietary Supplement: nitrate-rich beetroot juice |
| Group P | Placebo comparator | Dietary Supplement: nitrate-depleted beetroot juice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Han nationality
- Montreal Cognitive Assessment(MoCA) score >11
- Diagnosis of alcohol dependence
Key exclusion criteria (9 listed)
- Past or current infectious disease
- Past or current heart, brain, liver, kidney, and other severe diseases
- Past or current metabolic diseases that can lead to abnormalities of the immune system, such as obesity (Body Mass Index > 30 kg/m2), diabetes, or rheumatoid arthritis
- Past or current neurodegenerative diseases, such as Parkinson's disease
- Use of steroidal and non-steroidal anti-inflammatory drugs, antibiotics, antioxidants, and immunosuppressive agents within two months of enrollment
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 | Group N |
| nitrate-depleted beetroot juicenitrate-depleted beetroot juice, ~1 mg NO3- /d | Dietary supplement | Group P |
Primary outcome
Changes of Delayed Match to Sample Percent Correct (all delays) from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Test by DMS-PCAD (Delayed Match to Sample Percent Correct , all delays)
Changes of Spatial Working Memory Between Errors from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Test by SWM-BE (The Spatial Working Memory Between Errors )
20 secondary outcomes
Changes of oral microbiota from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of gut microbiota from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Delayed Match to Sample Percent Correct (0 seconds delay) from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Delayed Match to Sample Percent Correct (4 seconds delay) from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Delayed Match to Sample Percent Correct (12 seconds delay) from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Spatial Working Memory errors 4 boxes from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Spatial Working Memory errors 6 boxes from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Spatial Working Memory errors 8 boxes from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Intra-Extra Dimensional Set Shift test Stages Completed from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Intra-Extra Dimensional Completed Stage Errors from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Cambridge Gambling Decision Making Quality Total Merged from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Cambridge Gambling Delay Aversion Total from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Reaction Time Median Five-Choice Movement Time from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Reaction Time Median Five-Choice Reaction Time from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Rapid Visual Information Processing test Probability of False Alarm from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Rapid Visual Information Processing test A prime from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of Rapid Visual Information Processing test Median Response Latency from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of nitrate levels in serum from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Changes of nitrite levels in serum from baseline to post-intervention
Time frame: baseline and post-intervention(two weeks after baseline test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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. This study is not recruiting at the moment.
Hongqiang Sun principal investigator
Peking University Sixth Hospital
Liangjun Pang study chair
Anhui mental health central
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitrate-rich beetroot juice and nitrate-depleted beetroot juice in people with Microtia and Alcohol Dependence, run by Peking University Sixth Hospital at 1 site in China.
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 9 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Delayed Match to Sample Percent Correct (all delays) from baseline to post-intervention (time frame: baseline and post-intervention(two weeks after baseline test)). The study lists 2 primary outcomes in all. 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 3 Jun 2025.