- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414875
Acute Effect of Apple Cider Vinegar on Postprandial Plasma Malondialdehyde in Adult With Obesity
Acute Effect of Apple Cider Vinegar Consumption on Postprandial Plasma Malondialdehyde Level in Adult With Obesity
Research on the benefits of apple cider vinegar has tended to focus on its hypoglycemic effects and lipid profile changes during long-term consumption, without exploring its acute effects on oxidative stress during short-term consumption. Therefore, this study aimed to determine whether apple cider vinegar consumption affects postprandial plasma MDA levels in obese adults. The hypothesis of this study is that apple cider vinegar consumption has an acute effect on changes in postprandial plasma MDA levels in obese adult subjects.
Subject criteria are adults aged 19-59 years; obese nutritional status; based on a BMI of ≥ 25.0 kg/m² (according to the Asia-Pacific classification); in good general health. Exclusion criteria include pregnancy, breastfeeding, and menopause; consuming alcohol; intolerance to apple cider vinegar or fermented products.
This preliminary study, a parallel, randomized, open-label, controlled clinical trial, compared two groups: a control group receiving a standard diet without apple cider vinegar, and an intervention group receiving a standard diet with a single dose of apple cider vinegar.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This preliminary study is designed as a parallel, randomized, open-label, controlled clinical trial to evaluate the acute effect of apple cider vinegar (ACV) on postprandial oxidative stress in adults with obesity.
Obesity is strongly associated with increased oxidative stress and enhanced lipid peroxidation, particularly in the postprandial state. Malondialdehyde (MDA) is a widely used biomarker of lipid peroxidation and reflects oxidative damage to cell membranes. Postprandial increases in MDA may contribute to cardiometabolic risk. Apple cider vinegar contains acetic acid and bioactive compounds that may modulate postprandial metabolic responses and potentially attenuate oxidative stress. However, clinical evidence regarding its acute effect on postprandial lipid peroxidation in adults with obesity remains limited.
Eligible participants will be randomly assigned to either a control group (standard meal without ACV) or an intervention group (single dose of ACV prior to a standardized meal). The intervention consists of 15 mL of apple cider vinegar diluted in 250 mL of water, consumed within 5 minutes. The control group will receive 250 mL of water under identical conditions. Fifteen minutes after beverage consumption, participants will consume a standardized meal within 30 minutes.
To minimize confounding factors affecting oxidative stress, participants will undergo a one-week run-in period during which they will receive balanced diet education and be instructed to avoid antioxidant supplements and unusual strenuous physical activity. Additional dietary and lifestyle restrictions will be applied 24 hours prior to the intervention. Participants will fast overnight (10:00 PM-8:00 AM) before the study visit.
Venous blood samples will be collected in the fasting state (baseline) and 3 hours after meal consumption to assess changes in plasma malondialdehyde concentration. Lipid peroxidation will be quantified using high-performance liquid chromatography (HPLC) analysis of MDA-thiobarbituric acid (TBA) adducts.
The required sample size was calculated using a two-group comparison formula with an additional allowance for potential dropout. Participants who do not comply with beverage or meal consumption requirements will be excluded from per-protocol analysis.
This study aims to determine whether a single pre-meal dose of apple cider vinegar can attenuate postprandial lipid peroxidation in adults with obesity and provide evidence for its potential role as a simple dietary strategy to reduce oxidative stress.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ika Handayani, MD
- Phone Number: 6281511207273
- Email: dr.ikahandayani05@gmail.com
Study Contact Backup
- Name: Ika Handayani
- Email: dr.ikahandayani05@gmail.com
Study Locations
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-
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Jakarta, Indonesia
- Recruiting
- Ministry of Youth and Sports of the Republic of Indonesia (KEMENPORA RI)
-
Contact:
- Defi Cynthia Dewi
- Phone Number: 6282213823156
- Email: deficynthia@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 19-59 years.
- Obese, based on a BMI of ≥ 25.0 kg/m² (according to the Asia-Pacific classification).
- In good general health.
- No diagnosed chronic diseases (e.g diabetes mellitus, heart disease, kidney disease, cancer, hepatitis, or chronic infections).
- Willing to participate in the entire study and sign an informed consent form.
Exclusion Criteria:
- Pregnant, breastfeeding, or menopausal women.
- Alcohol consumption.
- Intolerance to apple cider vinegar or fermented products.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Apple Cider Vinegar Group
Participants in this group received a single acute dose of apple cider vinegar administered before or with a standard test meal.
Plasma malondialdehyde levels were measured before and after the meal.
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A single oral dose of apple cider vinegar was administered before a standard test meal to assess post-meal changes in plasma malondialdehyde levels.
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No Intervention: Control Group
Participants in this group received a standard test meal without apple cider vinegar.
Plasma malondialdehyde levels were measured before and after the meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Postprandial Plasma Malondialdehyde Levels
Time Frame: Baseline (fasting) to 3 hours postprandial
|
Change in plasma malondialdehyde concentration from baseline (fasting) to the postprandial time point following acute administration of apple cider vinegar compared with control.
|
Baseline (fasting) to 3 hours postprandial
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ika Handayani, MD, Faculty of Medicine, University of Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-12-1899
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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