Clinical trial NCT05963659: 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
Overall status: COMPLETED
Phase: NA
Conditions: Microtia
Alcohol Dependence
Keywords: nitrate
oral microbiota
alcohol dependence
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of Delayed Match to Sample Percent Correct (all delays) from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Spatial Working Memory Between Errors from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
Secondary outcomes:
measure: Changes of oral microbiota from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of gut microbiota from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Delayed Match to Sample Percent Correct (0 seconds delay) from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Delayed Match to Sample Percent Correct (4 seconds delay) from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Delayed Match to Sample Percent Correct (12 seconds delay) from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Spatial Working Memory errors 4 boxes from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Spatial Working Memory errors 6 boxes from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Spatial Working Memory errors 8 boxes from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Intra-Extra Dimensional Set Shift test Stages Completed from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Intra-Extra Dimensional Completed Stage Errors from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Cambridge Gambling Task Risk Adjustment Merged: Risk adjustment from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Cambridge Gambling Decision Making Quality Total Merged from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Cambridge Gambling Delay Aversion Total from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Reaction Time Median Five-Choice Movement Time from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Reaction Time Median Five-Choice Reaction Time from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Rapid Visual Information Processing test Probability of False Alarm from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Rapid Visual Information Processing test A prime from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of Rapid Visual Information Processing test Median Response Latency from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of nitrate levels in serum from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Changes of nitrite levels in serum from baseline to post-intervention
timeFrame: baseline and post-intervention(two weeks after baseline test)
Other outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: Cytokine Tumor Necrosis Factor-a in serum
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: The blood biochemical related parameters includes liver enzymes (alanine aminotransferase and aspartate aminotransferase)
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: The blood biochemical related parameters blood fat (cholesterol, triglycerides, low density lipoprotein and high density lipoprotein
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: Cytokine Interleukin-1b in serum
timeFrame: baseline and post-intervention(two weeks after baseline test)
measure: Cytokine Interleukin-6 in serum
timeFrame: baseline and post-intervention (two weeks after baseline test)
measure: Cytokine Interleukin-10 in serum
timeFrame: baseline and post-intervention (two weeks after baseline test)
Locations:
city: Hefei
country: China
facility: Anhui mental health center
state: Anhui
Study officials:
affiliation: Peking University Sixth Hospital
name: Hongqiang Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: Anhui mental health central
name: Liangjun Pang
role: STUDY_CHAIR
References: