Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in P… (NCT07493707) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of an Intervention With Apple Cider Vinegar on Glycemic Variability and Lipid Profile in Patients With Type 2 Diabetes Mellitus
Mexico38 participantsStarted 2024-05-06
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short-term glycemic variability (%)
Timeframe: 14 days
Trial details
NCT IDNCT07493707
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran