Nitrate Modulates Cognitive Impairment Via Oral Microbiota.

NCT05963659 | Completed

• 1 other identifier: 20230630
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Microtia; Alcohol Dependence

Keywords

nitrate; oral microbiota; alcohol dependence

Outcome Measures

Primary Outcomes (2)

• Changes of Delayed Match to Sample Percent Correct (all delays) from baseline to post-intervention

  Test by DMS-PCAD (Delayed Match to Sample Percent Correct , all delays)

  baseline and post-intervention(two weeks after baseline test)

• Changes of Spatial Working Memory Between Errors from baseline to post-intervention

  Test by SWM-BE (The Spatial Working Memory Between Errors )

  baseline and post-intervention(two weeks after baseline test)

Secondary Outcomes (20)

• Changes of oral microbiota from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of gut microbiota from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of Delayed Match to Sample Percent Correct (0 seconds delay) from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of Delayed Match to Sample Percent Correct (4 seconds delay) from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

• Changes of Delayed Match to Sample Percent Correct (12 seconds delay) from baseline to post-intervention

  baseline and post-intervention(two weeks after baseline test)

Other Outcomes (7)

• Systolic and diastolic blood pressure

  baseline and post-intervention (two weeks after baseline test)

• Cytokine Tumor Necrosis Factor-a in serum

  baseline and post-intervention(two weeks after baseline test)

• The blood biochemical related parameters includes liver enzymes (alanine aminotransferase and aspartate aminotransferase)

  baseline and post-intervention (two weeks after baseline test)

Study Arms (2)

Group N

EXPERIMENTAL

Dietary Supplement: nitrate-rich beetroot juice

Group P

PLACEBO COMPARATOR

Dietary Supplement: nitrate-depleted beetroot juice

Interventions

nitrate-rich beetroot juice DIETARY_SUPPLEMENT

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

Group N

nitrate-depleted beetroot juice DIETARY_SUPPLEMENT

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

Group P

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Han nationality
• Montreal Cognitive Assessment(MoCA) score \>11
• Diagnosis of alcohol dependence

You may not qualify if:

• 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
• 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
• Current oral disease

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Study Sites (1)

Anhui mental health center

Hefei, Anhui, 230022, China

Location

MeSH Terms

Conditions

Congenital Microtia; Alcoholism

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hongqiang Sun

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

• Liangjun Pang

  Anhui mental health central

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor,Director

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 27, 2023
• Study Start: September 10, 2023
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)