Effect of an Alcohol-Free Extract From the Wine Industry on Blood Pressure in Individuals With High Blood Pressure and Grade 1 Hypertension. Randomized, Crossover, Controlled Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
By-products from the wine industry pose serious problems of management, both from an economic and environmental point of view. Although traditionally the use of by-products of the wine sector has been limited to the production of biogas and energy, or its use as animal feed or agricultural fertilizer, there is greater interest in the use of these by-products as a potential source of functional ingredients.
Cardiovascular diseases (CVD) are the main cause of mortality in Europe, with hypertension being one of the main CVD risk factors. It has been shown that lowering blood pressure through behavioral and pharmacological interventions significantly improves CVD. Currently, one of the most widely used pharmacological therapies to treat hypertension is based on the use of angiotensin converting enzyme (ACE) inhibitors such as Captopril or Enalapril. ACE plays a key role in arterial pressure regulation, catalyzing the production of angiotensin II, an octapeptide with potent vasoconstrictor activity. In addition, ACE catalyzes the inactivation of bradykinin, peptide with vasodilator activity. The evaluation of various potential by-products of the wine industry for the generation of functional ingredients showed that an extract from the wine industry presented beneficial effects on blood pressure in in vitro models as well as in vivo models using rats with hypertension.
详细描述
The main objective of the study is to evaluate the effect of daily intake of an extract from the wine industry on the change in systolic blood pressure values in individuals with high blood pressure and grade 1 hypertension.
Secondary objectives are to evaluate the effects of an extract from the wine industry on:
- The change in diastolic blood pressure values.
- The change in body weight, body mass index (BMI) and waist circumference.
- The change in the circulating values of total cholesterol, LDL-c, HDL-c, triglycerides and ApoB.
- The change in the atherogenic index of plasma, which combines triglycerides and HDL-c values and which is considered a good indirect indicator of LDL-c particle size and subclinical atherosclerosis.
- Glucose metabolism and insulin resistance.
- The change in the inflammation values analyzed by the marker high sensitivity C-reactive protein.
Study Design: Randomized, crossover, placebo-controlled and double-blind nutritional intervention trial.
The number of subjects in the study will be 40. After the pre-screening visit, the participants will be randomly divided into two groups of 20 participants, according to start the study by taking the extract from the wine industry or placebo for 5 weeks. At the end of the week 5 of the study, when the first treatment is finished, there will be a washing period for 3 weeks and then the treatment will be changed for another 5 weeks: a total of 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Men and women over 18 years of age.
- •Systolic blood pressure between 130- 159 mm Hg.
- •Not under pharmacological treatment or have completed pharmacological treatment at least one month before the start of the study with anti-hypertensive and/or with lipid-lowering drugs.
- •Sign the informed consent.
排除标准
- •BMI ≥ 35 kg/m^
- •Have a clinical history of chronic kidney disease, cardiovascular disease and/or cancer.
- •Be a smoker or ex-smoker in the last 6 months before inclusion in the study.
- •Present diabetes.
- •Take supplements with polyphenol components or aimed to lipid or blood pressure control during their participation in the study.
- •Take 2 or more Standard Beverage Units daily or 17 weekly for women, or take 4 or more Standard Beverage Units daily or 28 weekly for men.
- •Present some chronic gastrointestinal disease.
- •Present food intolerances and/or allergies related to the products of the study, such as hypersensitivity to maltodextrin and/or sulfites.
- •Being pregnant or intending to become pregnant.
- •Be in breastfeeding period.
- •Participate in or have participated in a clinical trial with drugs or nutritional intervention study in the last 30 days prior to inclusion in the study.
- •Being unable to follow the study guidelines.
结局指标
主要结局
Change in systolic blood pressure
时间窗: Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).
Systolic blood pressure will be measured using an automatic sphygmomanometer.
次要结局
- Height(At week 1.)
- Change in BMI(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in waist circumference(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in waist circumference to height ratio(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum total cholesterol levels.(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum HDL-c levels.(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Change in diastolic blood pressure(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Change in body weight(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in conicity index(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum glucose levels(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum insulin levels(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum C- Reactive protein levels(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR)(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum Triglycerides levels(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in LDL-c to HDL-c ratio(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in Plasma atherogenic index(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in intestinal microbiota composition(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in total cholesterol to HDL-c ratio(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum LDL-c levels.(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Changes in serum Apo B levels(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Change in Physical activity(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)
- Adverse events(Before (baseline) and after treatment period (5 weeks) for each of the two treatments (dry VLC and placebo).)