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

NCT07493707 | Active Not Recruiting

• 1 other identifier: 4706
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus 2

Keywords

type 2 diabetes; apple cider vinegar; glycemic variability; CGM; satiety

Outcome Measures

Primary Outcomes (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.

  14 days

Secondary Outcomes (14)

• Triglycerides (mg/dl)

  14 days

• Weight (kg)

  14 days

• Postprandial glucose (mg/dl/h)

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

• Postprandial insulin (mcg U/ml/h)

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

• Postprandial triglycerides (mg/dl/h)

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

Study Arms (2)

Apple cider vinegar

EXPERIMENTAL

15 ml of apple cider vinegar diluted in 250 ml of water per mouth twice daily

Dietary Supplement: Apple Cider Vinegar

Water

ACTIVE COMPARATOR

250 ml of natural water per mouth twice daily

Dietary Supplement: Apple Cider Vinegar

Interventions

Apple Cider Vinegar DIETARY_SUPPLEMENT

15 ml of apple cider vinegar twice daily

Apple cider vinegar; Water

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  PMID: 31451249 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20502468 BACKGROUND

• 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.

  PMID: 19269707 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Noninsulin-Dependent, 2; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Paloma Almeda-Valdes, MD, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: Randomized, crossover, open-label clinical trial

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: May 6, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ME (1)