Moderate Alcohol and Cardiovascular Health Trial

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

1. Age *50 years at screening
2. Postmenopausal, defined as 12 consecutive months without menstruation
3. Not alcohol naïve, defined by having consumed at least one drink of alcohol in the past five years
4. High risk for the occurrence of a (new) cardiovascular disease event, definition see protocol chapter 4.2.

Exclusion Criteria

1. High alcohol consumption, definition see protocol chapter 4.3.
2. Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd) total score of *6 on questions 7, 8, and 10
3. Within the 6 months prior to randomization, cardiovascular disease event (MI, revascularization procedure, or stroke)
4. AHA Class III-IV heart failure
5. History of alcohol or substance abuse (medical record confirmed or self-reported history)
6. Other intolerance or allergy to alcohol
7. Dual antiplatelet therapy
8. History of gastric bypass surgery
9. Any serious chronic liver disease (e.g., active hepatitis B and C infections) or liver tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transpeptidase [GGT]) >2 times the upper limit of the normal range using local standards
10. Personal history of any colon or liver cancer
11. Any other cancer with a life expectancy of less than 3 years
12. Diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
13. Mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
14. Estimated glomerular filtration rate (eGFR) <30 ml/min /1.73m2 or end-stage renal disease (ESRD)
15. Ongoing use of any medication for which alcohol consumption is contraindicated
16. A Patient Health Questionnaire (PHQ-9) *15 at screening
17. History of any organ transplant
18. Unintentional weight loss >10% in last 6 months
19. Currently participating in another clinical trial (intervention trial)
20. Not willing or able to provide a name and contact information for at least one additional contact person other than self
21. Diagnosis of dementia.
22. Investigator discretion regarding appropriateness of participation or concern about intervention adherence, examples include: moderate * severe psychiatric illness, behavioral concerns regarding likelihood of low adherence to trial protocol, a medical condition likely to limit survival to less than 3 years, or an advanced chronic disease, such as cognitive impairment without a dementia diagnosis dementia, or any condition that requires 24-hour care.
23. Not willing or able to provide a signed and dated informed consent form
24. Unable to successfully complete the washout period
25. Not willing or able to comply with all trial procedures