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

This study has been completed.
Sponsor:
Information provided by:
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00755924
First received: September 17, 2008
Last updated: August 17, 2010
Last verified: August 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Change in HDL-Cholesterol level [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755924

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

No publications provided

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
Study First Received: September 17, 2008
Last Updated: August 17, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014