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

Cholesterol, HDL Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755924
• Other study ID #: 03635-07-C
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2008
• Last updated: November 25, 2015
• Start date: June 2008
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholesterol, HDL

Intervention

Dietary Supplement:
• Vinegar
Apple cider vinegar 2 TBlsp/day

Other:
• Placebo
Water placebo colored with balsamic vinegar

Locations

Country	Name	City	State
United States	Park Nicollet Health Services	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HDL-Cholesterol level		12 months	No