Nitrate Modulates Cognitive Impairment Via Oral Microbiota.

Peking University Sixth Hospital

Status: Completed

Conditions: Microtia; Alcohol Dependence

Treatments: Dietary Supplement: nitrate-rich beetroot juice; Dietary Supplement: nitrate-depleted beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT05963659

20230630

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Group N

Experimental group

Treatment:

Dietary Supplement: nitrate-rich beetroot juice

Group P

Placebo Comparator group

Treatment:

Dietary Supplement: nitrate-depleted beetroot juice