NCT06319443

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

March 13, 2024

Last Update Submit

August 14, 2025

Conditions

Keywords

glucosecontinuous glucose monitoringvinegar

Outcome Measures

Primary Outcomes (2)

  • Average glucose

    The average blood glucose concentration for each 4-day period

    Four days

  • Glucose: time in range

    The average time over 4 days that blood glucose falls in the reference range

    Four days

Study Arms (2)

Liquid vinegar

EXPERIMENTAL

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).

Dietary Supplement: Liquid vinegar

Vinegar pill

PLACEBO COMPARATOR

One pill consumed daily in the morning.

Dietary Supplement: vinegar pill

Interventions

Liquid vinegarDIETARY_SUPPLEMENT

3.5 g acetic acid

Liquid vinegar
vinegar pillDIETARY_SUPPLEMENT

0.022 g acetic acid

Vinegar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • glucose intolerance (defined as one of the following: fasting glucose \>99 mg/dl; diagnosis of prediabetes or diabetes; history of gestational diabetes)
  • years of age or older
  • sedentary or moderately active (defined as a score ≤ 24 on the Godin-Shepard Leisure Time Physical Activity Questionnaire)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

850 PBC

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Liquid and pill vinegar will be the treatments. The pill is the 'control' as the level of acetic acid is below the amount needed for an antiglycemic effect (a fact not realized by the participant).
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This is a 9-day trial. Participants will be fitted with a continuous glucose monitor and follow their typical diet and activity patterns. Participants will be randomized to ingest 2 tablespoons of vinegar twice daily (diluted in water) or a vinegar pill for the first 4 days on the trial. On day 5 of the trial participants will consume the alternate treatment for trial days 5-8. Dietary intake will be recorded daily using a fitness app. Physical activity will be assessed at baseline and on study day 4 and 8. On day 9, participants will return to the test site for device removal.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Dean

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

March 26, 2024

Primary Completion

December 15, 2024

Study Completion

July 15, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations