Nitrate Modulates Cognitive Impairment Via Oral Microbiota.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group N
|
Dietary Supplement: nitrate-rich beetroot juice
nitrate-rich beetroot juice, ~750 mg NO3- /d
|
| Placebo Comparator: Group P
|
Dietary Supplement: nitrate-depleted beetroot juice
nitrate-depleted beetroot juice, ~1 mg NO3- /d
|
Outcome Measures
Primary Outcome Measures
- Changes of cognitive function from baseline to post-intervention [baseline and post-intervention(two weeks after baseline test)]
Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB
- Changes of oral microbiota from baseline to post-intervention [baseline and post-intervention(two weeks after baseline test)]
Saliva samples were used to test the composition of microbiota by 16S RNA sequencing.
- Changes of gut microbiota from baseline to post-intervention [baseline and post-intervention(two weeks after baseline test)]
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 [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
Secondary Outcome Measures
- Cytokine Interleukin-1b in serum [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
- Cytokine Interleukin-6 in serum [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
- Cytokine Interleukin-10 in serum [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
- Cytokine Tumor Necrosis Factor-a in serum [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
- The blood biochemical related parameters includes liver enzymes (alanine aminotransferase and aspartate aminotransferase) [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.
- The blood biochemical related parameters blood fat (cholesterol, triglycerides, low density lipoprotein and high density lipoprotein [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.
- Alcohol craving by Visual Analogue Scale（VAS） [baseline and post-intervention (two weeks after baseline test)]
Tested by Visual Analogue Scale（VAS）
- Alcohol craving [baseline and post-intervention (two weeks after baseline test)]
Tested by Tested by Penn Alcohol Craving Scale（PACS)
- Alcohol withdrawal assessment [baseline and post-intervention (two weeks after baseline test)]
Tested by Clinical Institute Withdrawal Assessment of Alcohol, revised（CIWA-AR）
- Alcohol craving by Alcohol Urge Questionnaire [baseline and post-intervention (two weeks after baseline test)]
Tested by Alcohol Urge Questionnaire
- depression [baseline and post-intervention (two weeks after baseline test)]
Test by Hamilton Depression Rating Scale
- anxiety [baseline and post-intervention(two weeks after baseline test)]
Test by Hamilton Anxiety Rating Scale
- Sleep Quality [baseline and post-intervention (two weeks after baseline test)]
Test by pittsburgh sleep quality index
- blood pressure [baseline and post-intervention (two weeks after baseline test)]
Test by blood pressure monitor
Eligibility Criteria
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
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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
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Irregular eating habits that affect the oral flora (except alcohol) in the previous two months
-
Current oral disease
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Sixth Hospital
Investigators
- Principal Investigator: Hongqiang Sun, Peking University Sixth Hospital
- Study Chair: Liangjun Pang, Anhui mental health central
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230630