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Completed

NCT Number: NCT00755924

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Park Nicollet Health Services

Minneapolis, Minnesota, 55416, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vinegar

Dietary Supplement

Apple cider vinegar 2 TBlsp/day

Placebo

Other

Water placebo colored with balsamic vinegar

Primary outcomes

  1. Change in HDL-Cholesterol level

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 19, 2008
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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