NCT03584581Unknown2 期
Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cholesterols levels
研究概览
简要总结
This study is designed to determine whether a standardized intervention in the health center and based on hygienic dietary measures and physical exercise, supplemented with a polyphenol extract in patients, achieves a greater benefit in the reduction of LDL cholesterol in dyslipidemias in the short term.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dyslipidemia without the need for pharmacological treatment, but with annual follow-up of their dyslipidemia and with baseline LDL-cholesterol values.
- •Patients to whom the annual analysis will be carried out for control of the lipid profile and who agree to postpone it during the month of the health education study.
- •Patients who undergo hygienic-dietetic intervention and exercise.
- •Patients willing to ingest the nutritional supplement of polyphenols that will be supplied to them.
- •Signed the informed consent.
排除标准
- •<18 years old.
- •High cardiovascular risk.
- •With pharmacological treatment.
- •With some previous chronic disease.
- •With some allergy to the compounds of the product and placebo according to the technical specifications.
研究组 & 干预措施
Olive polyphenols
Experimental
干预措施: Olive polyphenols (Dietary Supplement)
Control
Placebo Comparator
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Cholesterols levels
时间窗: 1 month
TC, HDL-C, LDL-C and TG.
次要结局
- BMI (kg/m2)(1 month)
- Blood pressure(1 month)
- Waist circumference (cm)(1 month)
研究者
Ernesto Cortés-Castell
Professor
Universidad Miguel Hernandez de Elche
研究点 (2)
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