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

NCT00755924 | Completed Phase 1

• 1 other identifier: 03635-07-C
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol, HDL

Outcome Measures

Primary Outcomes (1)

• Change in HDL-Cholesterol level

  12 months

Interventions

Vinegar DIETARY_SUPPLEMENT

Apple cider vinegar 2 TBlsp/day

Placebo OTHER

Water placebo colored with balsamic vinegar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those older than 18 years of age
• Park Nicollet Health Services patient

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Park Nicollet Health Services

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Interventions

Acetic Acid

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: July 1, 2010
• Last Updated: November 26, 2015

Record last verified: 2010-08

Locations

US (1)