Status:
COMPLETED
Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein
Lead Sponsor:
HealthPartners Institute
Conditions:
Cholesterol, HDL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a double-blinded randomized placebo controlled prospective clinical trial evaluating the impact of apple cider vinegar on serum HDL. 112 participants will be randomized to consume either 2 tab...
Eligibility Criteria
Inclusion
- Those older than 18 years of age
- Park Nicollet Health Services patient
Exclusion
- Because of a potential positive effect of vinegar on improving diabetes mellitus8 and the subsequent change in medication regime for diabetes diabetic patients will be excluded from this study. If this study finds that vinegar does increase HDL levels, a subsequent study of diabetic patients will be conducted.
- History of allergy to apple cider vinegar
- Those with a terminal illness
- Diagnosis of Inflammatory bowel disease
- Those with Immunosuppression diseases
- Patients on dialysis
- Severe psychiatric illness who are unable to consent or reliably participate
- No evidence of end stage renal disease
- Those who use alcohol greater than or equal to 2 drinks per day
- Those who take in \>3 tsp vinegar/day supplement
- Plans to increase exercise or begin diet during the protocol period
- Any use of niacin or niacin-like compounds
- Initiation of niacin, fibrates (eg gemfibrozil); statin or ezetimibe medication within the last 6 weeks or during the trial
- Inability to read English
- Age less than 18 years given clinical events would be unlikely in this population
- LDL greater than 160mg/dL and requires adjustment or addition of statin therapy (which could reduce HDL)
- History of liver failure in medical history review
- Current smoking (as this can reduce HDL levels and it would be unethical to require people to continue smoking during the study)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00755924
Start Date
June 1 2008
End Date
July 1 2010
Last Update
November 26 2015
Active Locations (1)
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1
Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55416