Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein

HealthPartners Institute

Status and phase

Completed

Phase 1

Conditions

Cholesterol, HDL

Treatments

Dietary Supplement: Vinegar

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00755924

03635-07-C

Details and patient eligibility

About

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 tablespoons of vinegar daily or a placebo containing a 2% balsamic vinegar solution in water. Baseline, two month and 4 month blood samples will be obtained for fasting lipids. The primary endpoint is met if HDL levels increase in the treatment arm versus baseline after 2 month intervention.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Those older than 18 years of age
Park Nicollet Health Services patient

Exclusion criteria

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)