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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755924
First Posted: September 19, 2008
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HealthPartners Institute
  Purpose
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.

Condition Intervention Phase
Cholesterol, HDL Dietary Supplement: Vinegar Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Change in HDL-Cholesterol level [ Time Frame: 12 months ]

Enrollment: 114
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Vinegar
    Apple cider vinegar 2 TBlsp/day
    Other: Placebo
    Water placebo colored with balsamic vinegar
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755924


Locations
United States, Minnesota
Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
  More Information

Responsible Party: Dr. Carmello Panetta, Park Nicollet Heart and Vascular Center/Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT00755924     History of Changes
Other Study ID Numbers: 03635-07-C
First Submitted: September 17, 2008
First Posted: September 19, 2008
Last Update Posted: November 26, 2015
Last Verified: August 2010