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Type 2 Diabetes Mellitus 2Apple vinegarNCT07493707

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

A study testing Apple Cider Vinegar in people with Type 2 Diabetes Mellitus 2, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 2 Diabetes Mellitus 2
What is being tested?
Apple Cider Vinegar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteMexico
Study dates
6 May 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Documented gastroparesis
  • Pregnancy or lactation
  • Use of rapid-acting prandial insulin or analogs

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, 14080

Other trials in Mexico

About this study

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.

Read the 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.
Being tested
Apple Cider Vinegar
Keywords
type 2 diabetes, apple cider vinegar, glycemic variability, CGM, satiety
Medical subject headings
Diabetes Mellitus, Noninsulin-Dependent, 2, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apple Cider VinegarDietary supplement

    15 ml of apple cider vinegar twice daily

Study groups in NCT07493707
Study groupRoleWhat they receive
Apple cider vinegarExperimental15 ml of apple cider vinegar diluted in 250 ml of water per mouth twice daily
Receives: Dietary Supplement: Apple Cider Vinegar
WaterActive comparator250 ml of natural water per mouth twice daily
Receives: Dietary Supplement: Apple Cider Vinegar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term glycemic variability (%)

    Short-term glycemic variability, assessed with coefficient of variation (%). It will be measured for 14 days using a continuous glucose monitor.

    Measured: 14 days

Secondary outcomes (14)
  1. Triglycerides (mg/dl)

    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

    Measured: 14 days

  2. Weight (kg)

    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

    Measured: 14 days

  3. Postprandial glucose (mg/dl/h)

    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: Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.

  4. Postprandial insulin (mcg U/ml/h)

    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: Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.

  5. Postprandial triglycerides (mg/dl/h)

    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: Measured at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test.

  6. Postprandial GLP-1 (pmol/l)

    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: Measured at 0 and 60 minutes during the mixed-meal tolerance test.

  7. Body fat (%)

    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.

    Measured: 14 days

  8. Visceral fat (L)

    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.

    Measured: 14 days

  9. Hunger

    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: Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test.

  10. Satiety

    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: Measured at 0, 60, and 120 minutes during a mixed-meal tolerance test.

  11. Nausea

    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.

    Measured: Assessed after two weeks of intervention.

  12. Vomiting

    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.

    Measured: Assessed after two weeks of intervention.

  13. Abdominal pain

    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.

    Measured: Assessed after two weeks of intervention.

  14. Appetite

    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.

    Measured: Assessed after two weeks of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start6 May 2024
  3. Primary completion1 Aug 2026
  4. Study completionDec 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, crossover, open-label clinical trial
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493707
Sponsor's protocol ID
4706
Acronym
Apple vinegar
Status last verified
Aug 2026
First submitted
16 Mar 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Khezri SS, Saidpour A, Hosseinzadeh N, Amiri Z. Beneficial effects of Apple Cider Vinegar on weight management, Visceral Adiposity Index and lipid profile in overweight or obese subjects receiving restricted calorie diet: A randomized clinical trial. Journal of Functional Foods. 2018 Apr;43:95-102.

  • Gheflati A, Bashiri R, Ghadiri-Anari A, Reza JZ, Kord MT, Nadjarzadeh A. The effect of apple vinegar consumption on glycemic indices, blood pressure, oxidative stress, and homocysteine in patients with type 2 diabetes and dyslipidemia: A randomized controlled clinical trial. Clin Nutr ESPEN. 2019 Oct;33:132-138. doi: 10.1016/j.clnesp.2019.06.006. Epub 2019 Jul 9.

    PubMed 31451249
  • Kausar S, Abbas MA, Ahmad H, Yousef N, Ahmed Z, Humayun N, et al. Effect of Apple Cider Vinegar in Type 2 Diabetic Patients with Poor Glycemic Control: A Randomized Placebo Controlled Design. International Journal of Medical Research & Health Sciences. 2019;8(2):149-159.https://es.scribd.com/document/633192102/effect-of-apple-cider- vinegar-in-type-2-diabetic-patients-with-poor-glycemic-control-a-randomized-placebo-controlled-des-2

  • Liatis S, Grammatikou S, Poulia KA, Perrea D, Makrilakis K, Diakoumopoulou E, Katsilambros N. Vinegar reduces postprandial hyperglycaemia in patients with type II diabetes when added to a high, but not to a low, glycaemic index meal. Eur J Clin Nutr. 2010 Jul;64(7):727-32. doi: 10.1038/ejcn.2010.89. Epub 2010 May 26.

    PubMed 20502468
  • Johnston CS, White AM, Kent SM. Preliminary evidence that regular vinegar ingestion favorably influences hemoglobin A1c values in individuals with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2009 May;84(2):e15-7. doi: 10.1016/j.diabres.2009.02.005. Epub 2009 Mar 9.

    PubMed 19269707

Questions about this trial

What is this clinical trial studying?

A study testing Apple Cider Vinegar in people with Type 2 Diabetes Mellitus 2, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 Mexico. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Short-term glycemic variability (%) (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07493707, which also lists 5 linked publications.

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 10 Aug 2026.

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