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

Sponsors

Lead sponsor: HealthPartners Institute

Source HealthPartners Institute
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 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.

Overall Status Completed
Start Date June 2008
Completion Date July 2010
Primary Completion Date August 2009
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in HDL-Cholesterol level 12 months
Enrollment 114
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Vinegar

Description: Apple cider vinegar 2 TBlsp/day

Intervention type: Other

Intervention name: Placebo

Description: Water placebo colored with balsamic vinegar

Eligibility

Criteria:

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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Location
facility
Park Nicollet Health Services
Location Countries

United States

Verification Date

August 2010

Responsible Party

Name title: Dr. Carmello Panetta

Organization: Park Nicollet Heart and Vascular Center/Park Nicollet Institute

Has Expanded Access No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov