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It is known that alcohol consumption can lead to cognitive impairment and dysregulation of inflammatory responses. A preliminary randomized controlled trial conducted by our research team has suggested that nitrate may improve cognition in hospitalized patients with alcohol dependence. To further expand the population and applicability, this study aims to explore the effects of nitrate on cognition in a real-world population of heavy drinkers. The researchers have designed a two-stage clinical trial: the first stage involves the analysis of existing data, and the second stage will recruit 43-54 new participants for a 14-day dietary inorganic nitrate (nitrate-rich beetroot juice, ~750 mg NO3- /d) intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RWS | Experimental | Interventions:Dietary Supplement: nitrate-rich beetroot juice |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrate-rich beetroot juice | Dietary Supplement | Nitrate-rich beetroot juice, ~750 mg NO3- /d |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of responders with a DMS-PCAD score improvement of 6 or more after intervention compared to baseline | Test by DMS-PCAD (Delayed Match to Sample Percent Correct , all delays) The score range is from 0% to 100%, with higher scores indicating better performance in visual memory and matching tasks. | baseline and post-intervention(two weeks after baseline test) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Spatial Working Memory Between Errors from baseline to post-intervention | Test by SWM-BE (The Spatial Working Memory Between Errors ) The SWM-BE score range is primarily based on the number of errors, typically ranging from 0 to 10 errors. The higher the score, the fewer the errors, and the better the performance. | baseline and post-intervention(two weeks after baseline test) |
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Inclusion Criteria:
A. Individuals with a history of heavy alcohol consumption (as defined below), who have continued heavy drinking within the past week and have no plans to quit drinking within the next month.
B. Individuals with a history of heavy alcohol consumption who are currently hospitalized due to alcohol dependence or alcohol use disorder, and are still undergoing treatment.
The CDC (Centers for Disease Control and Prevention) defines heavy alcohol consumption as follows: For males: more than 15 standard alcoholic drinks per week. For females: more than 8 standard alcoholic drinks per week. Here, one standard drink unit is approximately 14 grams of pure alcohol- C. A Montreal Cognitive Assessment (MoCA) score greater than 13.
Exclusion Criteria:
A. Individuals with a history of or current infectious diseases. B. Individuals with a history of or current severe cardiovascular, cerebrovascular, hepatic, or renal diseases.
C. Individuals who are allergic to any substances used in the trial, such as beets.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FUYU Song | Contact | +8613699266767 | songfy@163.com |
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| Changes of cognitive function from baseline to post-intervention | Test by Cambridge Neuropsychological Test Automatic Battery，CANTAB | baseline and post-intervention(two weeks after baseline test) |
| Changes of oral microbiota from baseline to post-intervention | Saliva samples were used to test the composition of microbiota by 16S RNA sequencing. | baseline and post-intervention(two weeks after baseline test) |
| Changes of inflammatory factors levels in serum from baseline to post-intervention | We collected serum sampleWs were used to test the levels of inflammatory factors by Elisa | baseline and post-intervention(two weeks after baseline test) |
| depression | Test by Self-Rating Depression Scale | baseline and post-intervention (two weeks after baseline test) |
| anxiety | Test by Self-Rating Anxiety Scale | baseline and post-intervention(two weeks after baseline test) |
| Sleep Quality | Test by pittsburgh sleep quality index | baseline and post-intervention (two weeks after baseline test) |
| Cognitive | Test by Montreal Cognitive Assessment | baseline and post-intervention (two weeks after baseline test) |
| Dream | Test by Dream Evaluation Scale | baseline and post-intervention (two weeks after baseline test) |