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Clinical Trial NCT07493707 (Apple vinegar) for Type 2 Diabetes Mellitus 2 is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus (Apple vinegar) 38 Randomized Crossover Design Open-Label
Clinical Trial NCT07493707 (Apple vinegar) is an interventional study for Type 2 Diabetes Mellitus 2 that is active, not recruiting. It started on 6 May 2024 with plans to enroll 38 participants. Led by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 we...Show More
Detailed Description
- 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,...
Official Title
Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus
Conditions
Type 2 Diabetes Mellitus 2Publications
Scientific articles and research papers published about this clinical trial:- 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.
Other Study IDs
- Apple vinegar
- 4706
NCT ID Number
Start Date (Actual)
2024-05-06
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
38
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
type 2 diabetes
apple cider vinegar
glycemic variability
CGM
satiety
apple cider vinegar
glycemic variability
CGM
satiety
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalApple cider vinegar 15 ml of apple cider vinegar diluted in 250 ml of water per mouth twice daily | Apple Cider Vinegar 15 ml of apple cider vinegar twice daily |
Active ComparatorWater 250 ml of natural water per mouth twice daily | Apple Cider Vinegar 15 ml of apple cider vinegar twice daily |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 14 days |
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 | 14 days |
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 at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test. |
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 at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test. |
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 at 0, 30, 60, 90, and 120 minutes during the mixed-meal tolerance test. |
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 at 0 and 60 minutes during the mixed-meal tolerance test. |
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. | 14 days |
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. | 14 days |
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 at 0, 60, and 120 minutes during a mixed-meal tolerance test. |
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 at 0, 60, and 120 minutes during a mixed-meal tolerance test. |
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. | Assessed after two weeks of intervention. |
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. | Assessed after two weeks of intervention. |
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. | Assessed after two weeks of intervention. |
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. | Assessed after two weeks of intervention. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranStudy Responsible Party
Paloma Almeda-Valdés, Principal Investigator, Staff Physician, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
No contact data.
1 Study Locations in 1 Countries
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, 14080, Mexico