NCT00755924
Completed
Phase 1
Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein
ConditionsCholesterol, HDL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cholesterol, HDL
- Sponsor
- HealthPartners Institute
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Change in HDL-Cholesterol level
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in HDL-Cholesterol level
Time Frame: 12 months
Study Sites (1)
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