跳至主要内容
临床试验/NCT03906539
NCT03906539已完成4 期

Effect of Virgin Coconut Oil (VCO) on Cardiometabolic Parameters in Patients With Dyslipidemia: A Randomized, add-on, Placebo-controlled Clinical Trial

All India Institute of Medical Sciences, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年5月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Change in serum High Density Lipoprotein (HDL)

研究概览

简要总结

The present research will help to assess the effect of virgin coconut oil on cholesterol level and also will help to know whether virgin coconut oil can reduce the risk of heart diseases or not.

详细描述

Dyslipidemia is a well-established risk factor for cardiovascular (CV) diseases. Lipid abnormalities, including high levels of low-density lipoprotein cholesterol (LDL-C), elevated triglycerides and low levels of high-density lipoprotein cholesterol (HDL-C), are independent predictors of CV disease. The National Cholesterol Education Program Adult Treatment Panel III (ATP III) guideline and the American College of Cardiology (ACC) and American Heart Association (AHA) guideline recommend the use of statins for primary prevention based on a patient's cardiovascular risk profile and low-density lipoprotein cholesterol (LDL-C) level. However, statin therapy may be insufficient for patients with mixed dyslipidemia, especially those with metabolic syndromes. While the addition of niacin, fibrate or ezetimibe may be useful in this setting, the combination therapy may lead to more adverse drug reactions.

Virgin Coconut Oil (VCO), a nutraceutical, is an oil obtained from the fresh, mature kernel of the coconut by mechanical or natural means, with or without the use of heat and without undergoing chemical refining and it contains a considerable amount of medium-chain fatty acids similar to those in mother's milk. The beneficial effects of VCO in the reduction of cardiovascular risk have been proved from previous animal and clinical studies. The previous study demonstrated the potential beneficiary effect of VCO in lowering lipid levels in serum and LDL oxidation by physiological oxidants and this property of VCO was attributed to the biologically active polyphenol components present in the oil. It has been also demonstrated the hypolipidemic effect of VCO through activation of lipoprotein lipase, lecithin cholesterol acyltransferase and enhanced formation of bile acids. It was found that isolated polyphenols from VCO can prevent cadmium-induced lipid abnormalities and cardiovascular risk ratios by improving antioxidant defence systems. VCO may improve cardiovascular and hepatic complications in obesity. The findings from another study suggest a beneficial effect of VCO on lipid profile, renal status, hepatic antioxidant defence system, and cardiovascular risk indices in rats. It has been observed that VCO increased HDL-C level in patients with coronary artery disease (CAD). In a randomized crossover trial, it was found that daily consumption of VCO in young healthy adults significantly increased high-density lipoprotein cholesterol without any safety issues.

Our literature search revealed that to date, no clinical trial evaluated the potential of VCO as an add-on hypolipidemic agent in patients suffering from dyslipidemia. So, the present clinical trial has been designed to evaluate the effect of VCO on cardiometabolic parameters as an add-on with statins in patients with dyslipidemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with dyslipidemia [diagnosis of dyslipidemia is made when either of the lipid abnormality is present: LDL-C >140mg/dl, HDL-C <40mg/dl, Triglyceride >150mg/dl according to diagnostic criteria of dyslipidemia ]
  • Patients aged 18-65 years, of either sex.
  • Treatment-naive patients or patients who had not taken any treatment for at least 2 weeks before inclusion.

排除标准

  • History of any cardiovascular diseases, stroke, diabetes, malignancy, musculoskeletal or hepatic diseases
  • History of hypersensitivity to statins or coconut oil
  • Patients who are already under treatment for the presenting conditions.
  • Patients with drug/alcohol abuse.
  • Pregnant and nursing women.

研究组 & 干预措施

Control Group

Placebo Comparator

The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.

干预措施: Atorvastatin 10mg (Drug)

Control Group

Placebo Comparator

The patients in control groups will receive tablet atorvastatin (10 mg/day) and a placebo capsule.

干预措施: Placebo (Other)

VCO Group

Experimental

The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).

干预措施: Atorvastatin 10mg (Drug)

VCO Group

Experimental

The VCO group will receive capsule VCO (1000mg/day) as an add-on to tablet atorvastatin (10 mg/day).

干预措施: Virgin Coconut Oil (VCO) (Dietary Supplement)

结局指标

主要结局

Change in serum High Density Lipoprotein (HDL)

时间窗: Baseline and 8 weeks

Will be measured by autoanalyser

次要结局

  • Change in Cardiovascular risk index(Baseline and 8 weeks)
  • Change in serum Lipoprotein (a)(Baseline and 8 weeks)
  • Change in Atherogenic index(Baseline and 8 weeks)
  • Change in Coronary risk index(Baseline and 8 weeks)
  • Change in visceral fat(Baseline and 8 weeks)
  • Change in lipid peroxidation(Baseline and 8 weeks)
  • Change in serum Low Density Lipoprotein (LDL)(Baseline and 8 weeks)
  • Change in serum Very Low Density Lipoprotein (VLDL)(Baseline and 8 weeks)
  • Change in serum total cholesterol(Baseline and 8 weeks)
  • Change in serum triglyceride(Baseline and 8 weeks)

研究者

发起方
All India Institute of Medical Sciences, Bhubaneswar
申办方类型
Other
责任方
Principal Investigator
主要研究者

RITUPARNA MAITI

Additional Professor

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

Loading locations...

相似试验

Effect of Virgin Coconut Oil (VCO) on... | 临床试验