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临床试验/NCT06595472
NCT06595472已完成不适用

Effect of Plant Sterol-Enriched Palm Oil on Lipid Profile and Systemic Inflammation in Hyperlipidemic Adults: A Placebo-Controlled Double-Blinded Trial

Institut Pertanian Bogor0 个研究点目标入组 102 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
主要终点
Blood lipid profile

研究概览

简要总结

This is a placebo-controlled double-blinded trial aimed to evaluate the effect of palm oil enriched with plant sterols on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. Subjects were assigned to intervention oil which contained plant sterol and control oil which was the same as the intervention oil but did not contain plant sterol for 8 weeks. Data collected included nutritional status, energy and macronutrients consumption, blood lipid profile and inflammatory marker (hsCRP).

详细描述

Cardiovascular diseases, including coronary heart disease (CHD), are currently positioned amongst the leading causes of mortality globally. Risk factors of CHD include, among others, hypercholesterolemia and elevations in systemic inflammation. Functional foods enriched with compounds showing cholesterol-lowering effects are considered as one among various dietary and lifestyle intervention strategies to tackle this problem. A CHD-preventive effect of dietary plant sterols has been broadly discussed, not only due to their ability to reduce blood cholesterol level, but also to their proven anti-inflammatory potential. Palm oil is one amongst the most widely consumed edible oils in the world. Up to date, despite its widespread use, especially in Asian countries, no study has been conducted using palm oil as a vehicle for plant sterols. The aim of the placebo-controlled double-blinded trial presented here was therefore to evaluate the effect of palm oil enriched with plant sterols, used as a cooking oil, on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. The study had 2 arms; intervention group in which subjects were given oil which contained plant sterol and control group which in which subjects were given the same oil as the intervention group but did not contain plant sterol for 8 weeks. The oil was consumed as cooking oil. Data on energy, macro nutrients, and cooking oil consumption were collected through interviews at baseline, week 2, 4, 6, and endline. Body weight and height measurement for nutritional status assessment and blood sample collection for biomarker analysis was conducted at baseline and endline.

研究设计

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

盲法说明

The treatment and control cooking oil were indistinguishable in appearance and taste. The investigators and participants remained blinded to individual subject assignment throughout the study.

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 25-60y
  • total cholesterol concentration ≥200 mg/dL
  • not requiring lipid-lowering drug therapy during the trial

排除标准

  • secondary hyperlipidemia
  • fasting triglyceride concentration >3.5 mmol/L
  • body mass index >35 kg/m2
  • use of any lipid-lowering drug
  • suffering from gastrointestinal diseases or severe concomitant diseases

结局指标

主要结局

Blood lipid profile

时间窗: 8 weeks

Concentration of blood HDL, LDL, triacylglycerols, and cholesterol (total) of participants after intervention period.

次要结局

  • Inflammatory marker(8 weeks)

研究者

发起方
Institut Pertanian Bogor
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mira Dewi

Dr, Assistant Professor, Principal Investigator, Head of Health and Nutrition Division at Seafast Center IPB

Institut Pertanian Bogor

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