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

November 25, 2015 updated by: HealthPartners Institute

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.

Study Overview

Status

Completed

Conditions

Cholesterol, HDL

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55416
    - Park Nicollet Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HDL-Cholesterol level Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 17, 2008

First Submitted That Met QC Criteria