Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus (Apple vinegar)

August 5, 2026 updated by: Paloma Almeda-Valdés, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
The objective of this open-label, randomized, crossover clinical trial is to determine the effect of consuming 15 ml of organic apple cider vinegar on glycemic variability, measured by the coefficient of variation of glucose, in adults with type 2 diabetes mellitus. The main question this study seeks to answer is: What is the effect of consuming 15 ml of organic apple cider vinegar every 12 hours for a period of 2 weeks on the coefficient of variation of glucose in adults aged 18 to 60 years with type 2 diabetes mellitus, compared to consuming 250 ml of natural water? The researchers will compare the consumption of organic apple cider vinegar with natural water to evaluate whether organic apple cider vinegar has an impact on glycemic variability. Participants, in a crossover design, will use a continuous glucose monitor throughout the study. In one phase, they will consume 15 ml of apple cider vinegar before breakfast and before dinner for a period of 14 days, and in the other phase, they will consume 250 ml of natural water for the same period, with a washout period between both phases. Glucose data obtained through the continuous glucose monitor will be used to calculate the coefficient of variation as the primary measure of glycemic variability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Background and Rationale Type 2 diabetes mellitus (T2DM) represents a significant public health challenge worldwide, characterized by hyperglycemia resulting from insulin resistance and relative insulin secretion deficiency. The management of T2DM focuses on glycemic control to prevent micro- and macrovascular complications. While glycosylated hemoglobin (HbA1c) is a standard measure of long-term glycemic control, it has limitations in detecting short-term glucose fluctuations, known as glycemic variability. Growing evidence suggests that high glycemic variability is associated with an increased risk of complications, independent of average HbA1c.

    Apple cider vinegar (ACV) has gained attention as a potential adjunct for glucose management. Among the main proposed mechanisms by which vinegar might have some effect on glucose metabolism are the modulation of gastric emptying and the improvement of insulin sensitivity, according to preliminary studies. However, evidence on its specific impact on glycemic variability in adults with T2DM is limited and requires rigorous investigation. This clinical trial seeks to address this knowledge gap by evaluating the effect of organic apple cider vinegar consumption on glycemic variability, using the coefficient of variation (CV) of glucose as the primary outcome measure, compared to a natural water control.

  2. Study Design:

    An open-label, randomized, crossover clinical trial will be implemented. The crossover design will allow each participant to act as their own control, reducing inter-individual variability and increasing statistical power. Eligible participants will be randomized to one of two treatment sequences: (A) 14 days of consuming 15 ml of organic apple cider vinegar twice daily, followed by a one-week washout period, and then 14 days of consuming 250 ml of natural water twice daily; or (B) 14 days of consuming 250 ml of natural water twice daily, followed by a one-week washout period, and then 14 days of consuming 15 ml of organic apple cider vinegar twice daily. The one-week washout period aims to minimize any residual effects of the previous intervention before the next phase.

  3. Study Population:

    Approximately 38 adult participants (men and women) aged 18 to 60 years with a confirmed diagnosis of type 2 diabetes mellitus who meet the inclusion criteria will be recruited. Recruitment will be carried out for the general public. Written informed consent will be obtained from all participants before their inclusion in the study.

    During the apple cider vinegar intervention phase, participants will consume 15 ml of organic apple cider vinegar diluted in 250 ml of water before breakfast and dinner. During the control phase, participants will consume 250 ml of natural water at the same times. Participants will be instructed to maintain their usual dietary and physical activity habits throughout the study and to avoid the consumption of other products containing vinegar.

  4. Outcome Measures The primary outcome measure will be the change in glycemic variability, quantified by the coefficient of variation (CV) of glucose. Glucose data will be obtained from a continuous glucose monitor (CGM) that participants will use for the 14 days of each intervention phase. The CV will be calculated for each participant in each phase using all available glucose data during the intervention period.

    Secondary outcome measures include:

    Changes in body composition (percentage of fat mass, weight, and visceral fat) measured at the beginning and end of each phase using bioelectrical impedance.

    Changes in serum triglyceride concentrations, measured by venous blood analysis drawn at the beginning and end of each phase.

    Changes in the subjective perception of hunger and satiety, assessed using the Visual Analog Scale administered during a mixed meal tolerance test.

  5. Statistical Analysis Descriptive Variables Normality: Normality analysis will be performed using the Shapiro-Wilk test. Continuous quantitative variables with normal distribution: Data will be presented as means and standard deviations.

    Continuous quantitative variables without normal distribution: Data will be presented as medians and quartiles (Q1-Q3).

    Qualitative variables: Qualitative variables will be presented as frequency and percentage.

    Comparison between participants with and without apple cider vinegar Data will be captured and analyzed using the STATA statistical software version 16. A p-value less than 0.05 will be considered statistically significant.

    A multivariate analysis using multiple linear regression will be performed to evaluate the effect of apple cider vinegar, adjusting for other variables such as diet, physical activity level, and treatment for type 2 diabetes mellitus.

  6. Ethical Considerations This study will be conducted in compliance with the ethical principles of the Declaration of Helsinki and has been approved by the research and ethics committee of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Written informed consent will be obtained from all participants before their inclusion. The confidentiality of participants' personal and medical information will be guaranteed throughout the study and in the dissemination of the results.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women
  • Diagnosis of type 2 diabetes mellitus
  • Age between 18 and 60 years
  • Glycated hemoglobin (HbA1c) ≤ 8%
  • Participant's ability to attend medical appointments, answer questionnaires, and undergo laboratory tests.
  • Participant's ability to wear a Freestyle® device.
  • Participant's acceptance and signature of informed consent.
  • Acceptance of the intervention (consumption of 30 ml of apple cider vinegar) and avoidance of vinegar-based dressings for the entire duration of the intervention.
  • Consent to participate in the study.

Exclusion Criteria:

  • Other types of diabetes
  • Chronic kidney disease (eGFR < 60 ml/min)
  • Allergy to apple cider vinegar
  • Use of systemic steroids at supraphysiological doses
  • Gastroesophageal reflux disease
  • Peptic ulcer disease
  • Documented gastroparesis
  • Pregnancy or lactation
  • Use of rapid-acting prandial insulin or analogs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apple cider vinegar
15 ml of apple cider vinegar diluted in 250 ml of water per mouth twice daily
Dietary supplement: Apple Cider Vinegar
15 ml of apple cider vinegar twice daily
Active Comparator: Water
250 ml of natural water per mouth twice daily
Dietary supplement: Apple Cider Vinegar
15 ml of apple cider vinegar twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short-term glycemic variability (%)
Time Frame: 14 days
Short-term glycemic variability, assessed with coefficient of variation (%). It will be measured for 14 days using a continuous glucose monitor.
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Triglycerides (mg/dl)
Time Frame: 14 days
The effect of consuming 15 ml of organic apple cider vinegar every 12 hours for two weeks on triglyceride concentration (mg/dl) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus
14 days
Weight (kg)
Time Frame: 14 days
The effect of consuming 15 ml of organic apple cider vinegar every 12 hours for two weeks on weight (kg) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus
14 days
Postprandial glucose (mg/dl/h)
Time Frame: Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.
The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial glucose area under the curve (mg/dl/h) will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus.
Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.
Postprandial insulin (mcg U/ml/h)
Time Frame: Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.
The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial area under the curve (mcg U/ml/h) will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus.
Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.
Postprandial triglycerides (mg/dl/h)
Time Frame: Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.
The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial triglyceride area under the curve (mg/dl/h) will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus.
Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.
Postprandial GLP-1 (pmol/l)
Time Frame: Measured at 0 and 60 minutes during the mixed-meal tolerance test.
The effect of consuming 15 mL of organic apple cider vinegar before a mixed-meal tolerance test on postprandial GLP-1 (pmol) concentrations will be assessed in adults aged 18 to 60 years with type 2 diabetes mellitus.
Measured at 0 and 60 minutes during the mixed-meal tolerance test.
Body fat (%)
Time Frame: 14 days
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on body fat (%) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
14 days
Visceral fat (L)
Time Frame: 14 days
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on visceral fat (L) will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
14 days
Hunger
Time Frame: Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test.
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on hunger, assessed using a visual analog scale for hunger and satiety, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test.
Satiety
Time Frame: Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test.
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on satiety, assessed using a visual analog scale for hunger and satiety, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test.
Nausea
Time Frame: Assessed after two weeks of intervention.
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on nausea, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
Assessed after two weeks of intervention.
Vomiting
Time Frame: Assessed after two weeks of intervention.
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on vomiting, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
Assessed after two weeks of intervention.
Abdominal pain
Time Frame: Assessed after two weeks of intervention.
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on abdominal pain, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
Assessed after two weeks of intervention.
Appetite
Time Frame: Assessed after two weeks of intervention.
The effect of consuming 15 mL of organic apple cider vinegar every 12 hours for two weeks on decreased appetite, assessed using an adverse effects questionnaire in which participants rate symptom intensity on a 0 to 10 scale, will be determined in adults aged 18 to 60 years with type 2 diabetes mellitus.
Assessed after two weeks of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paloma Almeda-Valdes, MD, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Participant Data (IPD) will be shared with qualified researchers upon reasonable request. Data will be de-identified to protect participant privacy. Requests will be reviewed by the research team, and data will be shared for academic and non-commercial purposes through a secure data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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