Expired Study
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Minneapolis, Minnesota 55416


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.


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)


Study is Available At:


Original ID:

03635-07-C


NCT ID:

NCT00755924


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

HealthPartners Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

114


Enrollment Type:

Actual


Study Dates

Start Date:June 2008
Completion Date:July 2010
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:August 2010
Last Changed Date:November 25, 2015
First Received Date:September 17, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in HDL-Cholesterol level
Time Frame:12 months
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Vinegar
Description:Apple cider vinegar 2 TBlsp/day
Intervention Type:Other
Name:Placebo
Description:Water placebo colored with balsamic vinegar

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:HealthPartners Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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