Nitrate's effect on cognitive impairment in alcohol-dependent patients
The Effect of Nitrate on Cognitive Function in Alcohol Dependence Patients and the Potential Microbiota Mechanism.
This study tests if drinking nitrate-rich beetroot juice can help improve thinking skills in people who are dependent on alcohol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | Peking University Sixth Hospital Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05963659 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of dietary inorganic nitrate on cognitive impairment in individuals with alcohol dependence. It involves a randomized controlled trial where 70 participants will receive either nitrate-rich beetroot juice or a placebo over a 14-day period. The researchers will analyze changes in oral microbiota through saliva samples to assess any cognitive improvements linked to dietary nitrate intake. The goal is to understand how modifying oral bacteria may influence cognitive function in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are Han nationality individuals diagnosed with alcohol dependence and a Montreal Cognitive Assessment score greater than 11.
Not a fit: Patients with severe comorbid conditions, neurodegenerative diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve cognitive function in patients with alcohol dependence.
How similar studies have performed: While the approach of using dietary nitrates is innovative, there is limited existing research specifically targeting cognitive impairment in alcohol dependence through oral microbiota modulation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hefei, Anhui
- Anhui mental health center — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Hongqiang Sun — Peking University Sixth Hospital
- Study coordinator: Xiangxue li
- Email: 2011210552@bjmu.edu.cn
- Phone: +8613719234046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.