Nitrate Modulates Cognitive Impairment Via Oral Microbiota.

NCT ID: NCT05963659

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Microtia Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group N

Group Type EXPERIMENTAL

nitrate-rich beetroot juice

Intervention Type DIETARY_SUPPLEMENT

nitrate-rich beetroot juice, \~750 mg NO3- /d

Group P

Group Type PLACEBO_COMPARATOR

nitrate-depleted beetroot juice

Intervention Type DIETARY_SUPPLEMENT

nitrate-depleted beetroot juice, \~1 mg NO3- /d

Interventions

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nitrate-rich beetroot juice

nitrate-rich beetroot juice, \~750 mg NO3- /d

Intervention Type DIETARY_SUPPLEMENT

nitrate-depleted beetroot juice

nitrate-depleted beetroot juice, \~1 mg NO3- /d

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Sixth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hongqiang Sun

Clinical Professor,Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongqiang Sun

Role: PRINCIPAL_INVESTIGATOR

Peking University Sixth Hospital

Liangjun Pang

Role: STUDY_CHAIR

Anhui mental health central

Locations

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Anhui mental health center

Hefei, Anhui, China

Site Status

Countries

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China

Other Identifiers

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20230630

Identifier Type: -

Identifier Source: org_study_id

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