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

Sponsor
HealthPartners Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00755924
Collaborator
(none)
114
Enrollment
1
Location
25
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vinegar
  • Other: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Jul 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Change in HDL-Cholesterol level [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Park Nicollet Health Services Minneapolis Minnesota United States 55416

Sponsors and Collaborators

  • HealthPartners Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00755924
Other Study ID Numbers:
  • 03635-07-C
First Posted:
Sep 19, 2008
Last Update Posted:
Nov 26, 2015
Last Verified:
Aug 1, 2010
Additional relevant MeSH terms:
Acetic Acid

Study Results

No Results Posted as of Nov 26, 2015