Cholesterol, HDLPhase 1NCT00755924
Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein
A Phase 1 study testing Vinegar in people with Cholesterol, HDL, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol, HDL
- What is being tested?
- Vinegar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those older than 18 years of age
- Park Nicollet Health Services patient
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Health Services
Minneapolis, Minnesota, 55416
About this study
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.
- Conditions
- Cholesterol, HDL
- Being tested
- Vinegar, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinegarDietary supplement
Apple cider vinegar 2 TBlsp/day
PlaceboOther
Water placebo colored with balsamic vinegar
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HDL-Cholesterol level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol, HDLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755924
- Sponsor's protocol ID
- 03635-07-C
- Status last verified
- Aug 2010
- First submitted
- 17 Sep 2008
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Evaluating the Impact of Vinegar on High Density Lipoprotein
- ClinicalTrials.gov ID
- NCT00755924
- Acronym / sponsor ID
- 03635-07-C
- Conditions
- Cholesterol, HDL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those older than 18 years of age
- Park Nicollet Health Services patient
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinegarApple cider vinegar 2 TBlsp/day | Dietary supplement | – |
| PlaceboWater placebo colored with balsamic vinegar | Other | – |
Primary outcome
Change in HDL-Cholesterol level
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
Related trials for Cholesterol, HDL
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruiting
Goji Berry and Vasomotor Symptoms Pilot Study
Vasomotor Symptoms
Not yet recruiting
Fish Oil and HDL Function in Patients on Maintenance Hemodialysis
Kidney Failure Chronic, Cardiovascular Disease
Recruiting
Effects of Goji vs. Fiber on Macular Degeneration
Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vinegar in people with Cholesterol, HDL, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HDL-Cholesterol level (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.