NCT04506749已完成不适用
Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects
Universidad Católica San Antonio de Murcia2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年11月11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
- 72
- 试验地点
- 2
- 主要终点
- Total Cholesterol
研究概览
简要总结
Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches depending on the product consumed (experimental product and placebo product) and single-center with the objective of evaluating the effect of the investigational product on cardiovascular risk reduction.
详细描述
Subjects who meet the selection criteria will make a total of two visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes (men or women) between 30 and 75 years of age, Caucasian.
- •Present body mass index between 20 and 32 Kg / m
- •Presenting fasting serum LDL-cholesterol levels equal to or greater than 110 mg / dL or total serum cholesterol equal to or greater than 180 mg / dL.
- •Volunteers capable of understanding the clinical study and willing to grant written informed consent and to comply with study procedures and requirements.
排除标准
- •Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
- •Subjects who have suffered an ischemic-vascular event in the last months.
- •Subjects in medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (ex: statins).
- •Subjects in treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...).
- •Subjects in treatment that affects body weight or appetite.
- •History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Subjects who are carrying out or intend to carry out any type of diet, low-calorie or not, during the study.
- •Subjects who have donated a minimum of 0.5L of blood in the last month Vegetarian subjects.
- •Subjects who have ingested omega 3 and / or 6 supplements in the last three months, (eg, fish oil, evening primrose oil, krill oil, or algae oil).
- •Subjects under treatment with niacin or fibrates.
- •Those subjects with alcohol abuse, or with excessive alcohol consumption (> 3 glasses of wine or beer / day) were excluded.
- •Patients undergoing major surgery in the last 3 months.
- •Smoking subjects or not, but in any case who have changed their nicotinic habits during their participation in the study.
- •Participation in another clinical trial in the three months prior to the study.
- •Lack of will or inability to comply with clinical trial procedures.
- •Subjects whose condition did not make them eligible for the study according to the researcher's criteria.
结局指标
主要结局
Total Cholesterol
时间窗: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
HDL - Cholesterol
时间窗: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
LDL - Cholesterol
时间窗: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
Triglycerides
时间窗: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
次要结局
- Oxidized LDL(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Superoxide Dismutase (SOD)(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Physical Activity Questionnaire(It is measured before and after the consumption time (56 days).)
- Glycosylated hemoglobin (HBA1c)(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Fat mass(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Muscle mass(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Body mass index(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Percentage of fat mass(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Interleukin-6 (IL-6)(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Assessing a change of blood pressure(Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured)
- Blood glucose(It is measured on an empty stomach, before and after the consumption time (56 days).)
- malondialdehyde (MDA)(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Proteins C Reactive (PCR)(It is measured on an empty stomach, before and after the consumption time (56 days).)
- Control of dietary intake(A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.)
- Liver safety variables(It is measured on an empty stomach, before and after the consumption time (56 days).)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
研究点 (2)
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