Oxidative StressNCT07414875
Acute Effect of Apple Cider Vinegar on Postprandial Plasma Malondialdehyde in Adult With Obesity
A study testing apple cider vinegar in people with Oxidative Stress and Obesity, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Obesity
- What is being tested?
- apple cider vinegar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Feb 2026to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant, breastfeeding, or menopausal women.
- Alcohol consumption.
- Intolerance to apple cider vinegar or fermented products.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Ministry of Youth and Sports of the Republic of Indonesia (KEMENPORA RI)
Jakarta, Jakarta Special Capital Region
About this study
Official title: 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.
Read the 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.
- Conditions
- Oxidative Stress, Obesity
- Being tested
- apple cider vinegar
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apple cider vinegarDietary supplement
A single oral dose of apple cider vinegar was administered before a standard test meal to assess post-meal changes in plasma malondialdehyde levels.
| Study group | Role | What they receive |
|---|---|---|
| Apple Cider Vinegar Group | Experimental | 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. Receives: Dietary Supplement: apple cider vinegar |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Postprandial Plasma Malondialdehyde Levels
Change in plasma malondialdehyde concentration from baseline (fasting) to the postprandial time point following acute administration of apple cider vinegar compared with control.
Measured: Baseline (fasting) to 3 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start4 Feb 2026
- Primary completion6 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned into two parallel groups: an apple cider vinegar intervention group and a control group. Each group receives a single acute intervention followed by postprandial assessment of plasma malondialdehyde levels.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ika Handayani, Universitas Indonesia
- Investigators
- Ika Handayani, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414875
- Sponsor's protocol ID
- 25-12-1899
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Apple Cider Vinegar Consumption on Postprandial Plasma Malondialdehyde Level in Adult With Obesity
- ClinicalTrials.gov ID
- NCT07414875
- Acronym / sponsor ID
- 25-12-1899
- Conditions
- Oxidative Stress, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned into two parallel groups: an apple cider vinegar intervention group and a control group. Each group receives a single acute intervention followed by postprandial assessment of plasma malondialdehyde levels.
| Arm | Type | Receives |
|---|---|---|
| Apple Cider Vinegar Group | Experimental | Dietary Supplement: apple cider vinegarParticipants 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. |
| Control Group | No intervention | –Participants in this group received a standard test meal without apple cider vinegar. Plasma malondialdehyde levels were measured before and after the meal. |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant, breastfeeding, or menopausal women.
- Alcohol consumption.
- Intolerance to apple cider vinegar or fermented products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apple cider vinegarA single oral dose of apple cider vinegar was administered before a standard test meal to assess post-meal changes in plasma malondialdehyde levels. | Dietary supplement | Apple Cider Vinegar Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ika Handayani, MD principal investigator
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apple cider vinegar in people with Oxidative Stress and Obesity, run by Universitas Indonesia at 1 site in Indonesia.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jun 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Postprandial Plasma Malondialdehyde Levels (time frame: Baseline (fasting) to 3 hours postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.