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Completed

NCT Number: NCT05963659

Nitrate Modulates Cognitive Impairment Via Oral Microbiota.

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.

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Key information

Conditions

Microtia Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Congenital Abnormalities Congenital Microtia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ear Diseases Mental Disorders Otorhinolaryngologic Diseases Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Anhui mental health center

Hefei, Anhui, 230022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Han nationality
  • Montreal Cognitive Assessment(MoCA) score >11
  • Diagnosis of alcohol dependence

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Nitrate-rich beetroot Juice

Dietary Supplement

nitrate-rich beetroot juice, ~750 mg NO3- /d

Nitrate-depleted beetroot juice

Dietary Supplement

nitrate-depleted beetroot juice, ~1 mg NO3- /d

Primary outcomes

  1. 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)

  2. 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 )

Secondary outcomes

  1. Changes of oral microbiota from baseline to post-intervention

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

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

  2. Changes of gut microbiota from baseline to post-intervention

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

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

  3. 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)

    Test by Delayed Match to Sample Percent Correct (0 seconds delay)

  4. 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)

    Test by Delayed Match to Sample Percent Correct (4 seconds delay)

  5. 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)

    Test by Delayed Match to Sample Percent Correct (12 seconds delay)

  6. Changes of Spatial Working Memory errors 4 boxes from baseline to post-intervention

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

    Test by The Spatial Working Memory errors 4 boxes

  7. Changes of Spatial Working Memory errors 6 boxes from baseline to post-intervention

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

    Test by The Spatial Working Memory errors 6 boxes

  8. Changes of Spatial Working Memory errors 8 boxes from baseline to post-intervention

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

    Test by The Spatial Working Memory errors 8 boxes

  9. 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)

    Test by The Intra-Extra Dimensional Set Shift test Stages Completed

  10. Changes of Intra-Extra Dimensional Completed Stage Errors from baseline to post-intervention

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

    Test by The Intra-Extra Dimensional Completed Stage Errors

  11. 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)

    Test by Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment

  12. 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)

    Test by Cambridge Gambling Decision Making Quality Total Merged

  13. Changes of Cambridge Gambling Delay Aversion Total from baseline to post-intervention

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

    Test by Cambridge Gambling Delay Aversion Total

  14. 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)

    Test by Reaction Time Median Five-Choice Movement Time

  15. 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)

    Test by Reaction Time Median Five-Choice Reaction Time

  16. 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)

    Test by the Rapid Visual Information Processing test Probability of False Alarm

  17. 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)

    Test by the Rapid Visual Information Processing test A prime

  18. 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)

    Test by the Rapid Visual Information Processing test Median Response Latency

  19. Changes of nitrate levels in serum from baseline to post-intervention

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

    The collected serum samples were used to test the levels of nitrate and nitrite by High Performance Liquid Chromatography \\ HPLC

  20. Changes of nitrite levels in serum from baseline to post-intervention

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

    The collected serum samples were used to test the levels of nitrate and nitrite by High Performance Liquid Chromatography \\ HPLC

Other outcomes

  1. Systolic and diastolic blood pressure

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

    Test by blood pressure monitor

  2. Cytokine Tumor Necrosis Factor-a in serum

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

    The collected serum samples were used to test the levels of TNF-a by Enzyme-Linked Immunosorbent Assay

  3. The blood biochemical related parameters includes liver enzymes (alanine aminotransferase and aspartate aminotransferase)

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

    The collected venous blood were sent to the department of clinical laboratory and the investigators recorded the laboratory report.

  4. The blood biochemical related parameters blood fat (cholesterol, triglycerides, low density lipoprotein and high density lipoprotein

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

    The collected venous blood were sent to the department of clinical laboratory and the investigators recorded the laboratory report.

  5. Cytokine Interleukin-1b in serum

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

    The collected serum samples were used to test the levels of IL-1b by Enzyme-Linked Immunosorbent Assay

  6. Cytokine Interleukin-6 in serum

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

    The collected serum samples were used to test the levels of IL-6 by Enzyme-Linked Immunosorbent Assay

  7. Cytokine Interleukin-10 in serum

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

    The collected serum samples were used to test the levels of IL-10 by Enzyme-Linked Immunosorbent Assay

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Registry information

Official study title

The Effect of Nitrate on Cognitive Function in Alcohol Dependence Patients and the Potential Microbiota Mechanism.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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