- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06319443
Daily Vinegar Ingestion and 24-Hour Blood Glucose Control
Daily Vinegar Ingestion and 24-Hour Blood Glucose Control in Adults With Glucose Intolerance: A Randomized Crossover Trial
When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7.
Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- 850 PBC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- glucose intolerance (defined as one of the following: fasting glucose >99 mg/dl; diagnosis of prediabetes or diabetes; history of gestational diabetes)
- 18 years of age or older
- sedentary or moderately active (defined as a score ≤ 24 on the Godin-Shepard Leisure Time Physical Activity Questionnaire)
Exclusion Criteria:
- currently adhering to a non-typical diet that would impact carbohydrate intake (including weight loss diets)
- medication/drug use that has not been consistent for the previous 3 months or will be discontinued during the trial
- any acute illness
- regular smokers, pregnant or lactating women, or individuals taking insulin
- Unwilling to tolerate vinegar ingestion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Liquid vinegar
Liquid vinegar (6% acidity) consumed at a dosage of 2 tablespoons (diluted in water and consumed at mealtime) twice daily (4 tablespoons total per day).
|
3.5 g acetic acid
|
|
Placebo Comparator: Vinegar pill
One pill consumed daily in the morning.
|
0.022 g acetic acid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average glucose
Time Frame: Four days
|
The average blood glucose concentration for each 4-day period
|
Four days
|
|
Glucose: time in range
Time Frame: Four days
|
The average time over 4 days that blood glucose falls in the reference range
|
Four days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00019235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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