Microtia, Alcohol Dependence
Conditions
Keywords
nitrate, oral microbiota, alcohol dependence
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.
Interventions
DIETARY_SUPPLEMENTnitrate-rich beetroot juice
nitrate-rich beetroot juice, \ 750 mg NO3- /d
DIETARY_SUPPLEMENTnitrate-depleted beetroot juice
nitrate-depleted beetroot juice, \ 1 mg NO3- /d
Sponsors
Peking University Sixth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Han nationality 2. Montreal Cognitive Assessment(MoCA) score \>11 3. Diagnosis of alcohol dependence
Exclusion criteria
1. Past or current infectious disease 2. Past or current heart, brain, liver, kidney, and other severe diseases 3. 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 4. Past or current neurodegenerative diseases, such as Parkinson's disease 5. Use of steroidal and non-steroidal anti-inflammatory drugs, antibiotics, antioxidants, and immunosuppressive agents within two months of enrollment 6. Use of probiotics and probiotics every day for the first two months before enrollment 7. 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 8. Irregular eating habits that affect the oral flora (except alcohol) in the previous two months 9. Current oral disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Delayed Match to Sample Percent Correct (all delays) from baseline to post-intervention | 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 | baseline and post-intervention(two weeks after baseline test) | Test by SWM-BE (The Spatial Working Memory Between Errors ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Spatial Working Memory errors 8 boxes from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by The Spatial Working Memory errors 8 boxes |
| Changes of Reaction Time Median Five-Choice Movement Time from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Reaction Time Median Five-Choice Movement Time |
| Changes of Reaction Time Median Five-Choice Reaction Time from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Reaction Time Median Five-Choice Reaction Time |
| Changes of Rapid Visual Information Processing test Probability of False Alarm from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by the Rapid Visual Information Processing test Probability of False Alarm |
| Changes of Rapid Visual Information Processing test A prime from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by the Rapid Visual Information Processing test A prime |
| Changes of Rapid Visual Information Processing test Median Response Latency from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by the Rapid Visual Information Processing test Median Response Latency |
| Changes of nitrate 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 |
| Changes of 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 |
| 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 Delayed Match to Sample Percent Correct (0 seconds delay) from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Delayed Match to Sample Percent Correct (0 seconds delay) |
| Changes of Delayed Match to Sample Percent Correct (4 seconds delay) from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Delayed Match to Sample Percent Correct (4 seconds delay) |
| Changes of Delayed Match to Sample Percent Correct (12 seconds delay) from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Delayed Match to Sample Percent Correct (12 seconds delay) |
| Changes of Spatial Working Memory errors 4 boxes from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by The Spatial Working Memory errors 4 boxes |
| Changes of Spatial Working Memory errors 6 boxes from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by The Spatial Working Memory errors 6 boxes |
| Changes of Intra-Extra Dimensional Set Shift test Stages Completed from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by The Intra-Extra Dimensional Set Shift test Stages Completed |
| Changes of Intra-Extra Dimensional Completed Stage Errors from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by The Intra-Extra Dimensional Completed Stage Errors |
| Changes of Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment |
| Changes of Cambridge Gambling Decision Making Quality Total Merged from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Cambridge Gambling Decision Making Quality Total Merged |
| Changes of Cambridge Gambling Delay Aversion Total from baseline to post-intervention | baseline and post-intervention(two weeks after baseline test) | Test by Cambridge Gambling Delay Aversion Total |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Systolic and diastolic blood pressure | baseline and post-intervention (two weeks after baseline test) | Test by blood pressure monitor |
| 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. |
Countries
China
Outcome results
None listed