Nitrate Modulates Cognitive Impairment Via Oral Microbiota.
China70 participantsStarted 2023-09-10
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕
What they're measuring
1
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)
2
Changes of Spatial Working Memory Between Errors from baseline to post-intervention
Timeframe: baseline and post-intervention(two weeks after baseline test)
. 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