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Nitrate Modulates Cognitive Impairment Via Oral Microbiota.

Primary Purpose

Microtia, Alcohol Dependence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nitrate-rich beetroot juice
nitrate-depleted beetroot juice
Sponsored by
Peking University Sixth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Microtia focused on measuring nitrate, oral microbiota, alcohol dependence

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group N

    Group P

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes of cognitive function from baseline to post-intervention
    Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB
    Changes of oral microbiota from baseline to post-intervention
    Saliva samples were used to test the composition of microbiota by 16S RNA sequencing.
    Changes of gut microbiota from baseline to post-intervention
    Feces samples were used to test the composition of microbiota by 16S RNA sequencing.
    Changes of nitrate and 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

    Secondary Outcome Measures

    Cytokine Interleukin-1b in serum
    The collected serum samples were used to test the levels of IL-1b by Enzyme-Linked Immunosorbent Assay
    Cytokine Interleukin-6 in serum
    The collected serum samples were used to test the levels of IL-6 by Enzyme-Linked Immunosorbent Assay
    Cytokine Interleukin-10 in serum
    The collected serum samples were used to test the levels of IL-10 by Enzyme-Linked Immunosorbent Assay
    Cytokine Tumor Necrosis Factor-a in serum
    The collected serum samples were used to test the levels of TNF-a by Enzyme-Linked Immunosorbent Assay
    The blood biochemical related parameters includes liver enzymes (alanine aminotransferase and aspartate aminotransferase)
    The collected venous blood were sent to the department of clinical laboratory and the investigators recorded the laboratory report.
    The blood biochemical related parameters blood fat (cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
    The collected venous blood were sent to the department of clinical laboratory and the investigators recorded the laboratory report.
    Alcohol craving by Visual Analogue Scale（VAS）
    Tested by Visual Analogue Scale（VAS）
    Alcohol craving
    Tested by Tested by Penn Alcohol Craving Scale（PACS)
    Alcohol withdrawal assessment
    Tested by Clinical Institute Withdrawal Assessment of Alcohol, revised（CIWA-AR）
    Alcohol craving by Alcohol Urge Questionnaire
    Tested by Alcohol Urge Questionnaire
    depression
    Test by Hamilton Depression Rating Scale
    anxiety
    Test by Hamilton Anxiety Rating Scale
    Sleep Quality
    Test by pittsburgh sleep quality index
    blood pressure
    Test by blood pressure monitor

    Full Information

    First Posted
    June 30, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Peking University Sixth Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05963659
    Brief Title
    Nitrate Modulates Cognitive Impairment Via Oral Microbiota.
    Official Title
    The Effect of Nitrate on Cognitive Function in Alcohol Dependence Patients and the Potential Microbiota Mechanism.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 7, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    August 7, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Sixth Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microtia, Alcohol Dependence
    Keywords
    nitrate, oral microbiota, alcohol dependence

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group N
    Arm Type
    Experimental
    Arm Title
    Group P
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    nitrate-rich beetroot juice
    Intervention Description
    nitrate-rich beetroot juice, ~750 mg NO3- /d
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    nitrate-depleted beetroot juice
    Intervention Description
    nitrate-depleted beetroot juice, ~1 mg NO3- /d
    Primary Outcome Measure Information:
    Title
    Changes of cognitive function from baseline to post-intervention
    Description
    Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB
    Time Frame
    baseline and post-intervention(two weeks after baseline test)
    Title
    Changes of oral microbiota from baseline to post-intervention
    Description
    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)
    Title
    Changes of gut microbiota from baseline to post-intervention
    Description
    Feces samples were used to test the composition of microbiota by 16S RNA sequencing.
    Time Frame
    baseline and post-intervention(two weeks after baseline test)
    Title
    Changes of nitrate and nitrite levels in serum from baseline to post-intervention
    Description
    The collected serum samples were used to test the levels of nitrate and nitrite by High Performance Liquid Chromatography \ HPLC
    Time Frame
    baseline and post-intervention(two weeks after baseline test)
    Secondary Outcome Measure Information:
    Title
    Cytokine Interleukin-1b in serum
    Description
    The collected serum samples were used to test the levels of IL-1b by Enzyme-Linked Immunosorbent Assay
    Time Frame
    baseline and post-intervention(two weeks after baseline test)
    Title
    Cytokine Interleukin-6 in serum
    Description
    The collected serum samples were used to test the levels of IL-6 by Enzyme-Linked Immunosorbent Assay
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    Cytokine Interleukin-10 in serum
    Description
    The collected serum samples were used to test the levels of IL-10 by Enzyme-Linked Immunosorbent Assay
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    Cytokine Tumor Necrosis Factor-a in serum
    Description
    The collected serum samples were used to test the levels of TNF-a by Enzyme-Linked Immunosorbent Assay
    Time Frame
    baseline and post-intervention(two weeks after baseline test)
    Title
    The blood biochemical related parameters includes liver enzymes (alanine aminotransferase and aspartate aminotransferase)
    Description
    The collected venous blood were sent to the department of clinical laboratory and the investigators recorded the laboratory report.
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    The blood biochemical related parameters blood fat (cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
    Description
    The collected venous blood were sent to the department of clinical laboratory and the investigators recorded the laboratory report.
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    Alcohol craving by Visual Analogue Scale（VAS）
    Description
    Tested by Visual Analogue Scale（VAS）
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    Alcohol craving
    Description
    Tested by Tested by Penn Alcohol Craving Scale（PACS)
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    Alcohol withdrawal assessment
    Description
    Tested by Clinical Institute Withdrawal Assessment of Alcohol, revised（CIWA-AR）
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    Alcohol craving by Alcohol Urge Questionnaire
    Description
    Tested by Alcohol Urge Questionnaire
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    depression
    Description
    Test by Hamilton Depression Rating Scale
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    anxiety
    Description
    Test by Hamilton Anxiety Rating Scale
    Time Frame
    baseline and post-intervention(two weeks after baseline test)
    Title
    Sleep Quality
    Description
    Test by pittsburgh sleep quality index
    Time Frame
    baseline and post-intervention (two weeks after baseline test)
    Title
    blood pressure
    Description
    Test by blood pressure monitor
    Time Frame
    baseline and post-intervention (two weeks after baseline test)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiangxue li
    Phone
    +8613719234046
    Email
    2011210552@bjmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hongqiang Sun
    Organizational Affiliation
    Peking University Sixth Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Liangjun Pang
    Organizational Affiliation
    Anhui mental health central
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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