Study of Nitrate-Rich Juice on Cognitive Function in Heavy Alcohol Drinkers: a Two-Stage Adaptive Design Real-World Clinical Trial

Launched by PEKING UNIVERSITY SIXTH HOSPITAL · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether drinking nitrate-rich juice, specifically beetroot juice, can help improve thinking and memory in people who drink heavily. Previous research suggested that nitrates might have positive effects on brain function, and now the researchers want to see if this holds true for a larger group of heavy drinkers in real-life situations. The study will be conducted in two stages: the first stage will look at existing data, and the second stage will invite 43-54 new participants to take part in a 14-day program where they will drink the nitrate-rich juice daily.

To be eligible for this trial, participants must have a history of heavy drinking, which means more than 15 drinks per week for men and more than 8 for women. They should also have been drinking heavily in the past week and not plan to stop drinking for the next month. Additionally, if they are currently in the hospital for alcohol-related issues, they can still participate. Participants will undergo some assessments and will be monitored throughout the study. It's important to note that individuals with certain health conditions or allergies to beets will not be able to join the trial.

Gender

ALL

Eligibility criteria

• 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.