Clinical Trial and Randomized Efficacy of a Natural Ingredient on the Arterial Tension of Normother Subjects or With Arterial Hypertension Grade i Without Pharmacological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Assessing a change of blood pressure five times
研究概览
简要总结
Randomized controlled trial with two parallel branches (experimental product and placebo), double blind and unicentric with which it is intended to evaluate the efficacy of the product under investigation against placebo on blood pressure of normotensive subjects or with hypertension grade I without Pharmacotherapy. The subjects that meet the selection criteria will make a total of five visits to the research laboratory and perform the tests that were pre-established in the protocol. Later, a statistical analysis will be carried out 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
- Prevention
- 盲法
- Double (Participant, Investigator)
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 between 18-65 years old.
- •Systolic blood pressure between 120 and 159 mmHg or diastolic blood pressure between 80 and 100 mm Hg. taken in basal conditions.
- •Volunteers able to understand the clinical study and willing to comply with the procedures and requirements of the study
排除标准
- •In pharmacological treatment of arterial hypertension.
- •Subjects with acute diseases.
- •Volunteers with a history or presence of chronic pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular or pathological conditions or malignant tumor disease that can modify the blood pressure of subjects.
- •Subjected to major surgery in the last 3 months.
- •Subjects who stopped smoking in the last 6 months or who intend to quit during the study.
- •Subjects with allergies or eating disorders.
- •Participation in another study that includes blood extractions or dietary intervention.
- •Pregnant woman.
- •Subjects whose condition does not make them eligible for the study, according to the researcher.
研究组 & 干预措施
Ëxperimental
Consumption during 84 days of Lippia citriodora 325 mg + Hibiscus sabdariffa 175 mg.
Two capsules a day will be consumed thirty minutes before breakfast for 84 days.
干预措施: nutraceutical: experimental product (Dietary Supplement)
Placebo
Consumption during 84 days of saccharose. Two capsules a day will be consumed thirty minutes before breakfast for 84 days.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Assessing a change of blood pressure five times
时间窗: Blood pressure measurements will be taken with a Holter on five separate occasions and for 24 hours each day. The measurements will be made at baseline and at 14, 28, 56 and 84 days of consumption of the product.
blood pressure is measured with a holter
次要结局
- Gastrointestinal well-being evaluation(The questionnaire will be completed five times (GIQLI). It will be completed at baseline (without consumption of the product), at 14, 28, 56 and 84 days of consumption of the experimental product.)
- quality of life questionnaire(The cuestionnaire will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use. The subjects have to answer 26 items on a scale of one to five, being one never and 5 always.)
- body composition(A record of body composition will be made five times during the 84 days of consumption. Measures will be taken at baseline, at 14 days, 28, 56 and 84 days.)
- Subjective sensation of product consumption(Subjects will complete the hedonic scale four times. at 14, 28, 56 and 84 days of consumption of the product under study.)
- Control of dietary intake(A nutritional registry will be carried out. The nutritional intake of for days in two periods will be collected. One record at the beginning and another at the end, that is, six days.)
- blood samples(Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 84 days of use.)
- physical activity(An accelerometer will be placed twice on the subjects. The first time at baseline and the second after taking 84 days of consumption of the product under study.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia