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临床试验/NCT07414875
NCT07414875已完成不适用

Acute Effect of Apple Cider Vinegar Consumption on Postprandial Plasma Malondialdehyde Level in Adult With Obesity

Indonesia University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Change in Postprandial Plasma Malondialdehyde Levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
19 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Pregnant, breastfeeding, or menopausal women.
  • Alcohol consumption.
  • Intolerance to apple cider vinegar or fermented products.

研究组 & 干预措施

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.

干预措施: apple cider vinegar (Dietary Supplement)

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.

结局指标

主要结局

Change in Postprandial Plasma Malondialdehyde Levels

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ika Handayani

Principal Investigator

Indonesia University

研究点 (1)

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