Nitrate Modulates Cognitive Impairment Via Oral Microbiota.
NCT ID: NCT05963659
Last Updated: 2025-06-03
Study Results
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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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-09-10
2024-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Group N
nitrate-rich beetroot juice
nitrate-rich beetroot juice, \~750 mg NO3- /d
Group P
nitrate-depleted beetroot juice
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
nitrate-depleted beetroot juice
nitrate-depleted beetroot juice, \~1 mg NO3- /d
Eligibility Criteria
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Inclusion Criteria
2. Montreal Cognitive Assessment(MoCA) score \>11
3. Diagnosis of alcohol dependence
Exclusion Criteria
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
18 Years
60 Years
MALE
No
Sponsors
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Peking University Sixth Hospital
OTHER
Responsible Party
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Hongqiang Sun
Clinical Professor,Director
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
Countries
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Other Identifiers
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20230630
Identifier Type: -
Identifier Source: org_study_id
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