Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change from mean blood pressure (MBP) at Day 21
研究概览
简要总结
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.
In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".
"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.
Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.
On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.
详细描述
This single-center, randomized study, aim to determine the difference in absorption between sodium depending on its nature: bicarbonate (NaHCO3) or chloride (NaCl), and the effect of those types of sodium on blood pressure.
In order to realize it, 206 volunteers will be include to assess whether or not they are a "NaCl sensitive volunteer" phenotype.
The study will be carried out on 34 of NaCl sensitive volunteer which will take the sodium dietary supplements. The 2 dietary supplements are table salt (sachet) or bottled water. They will be test in a cross-over design during 2 periods of 1 week separated from 1 week of a washing-out period.
The primary objective will be to compare mean arterial pressure (MAP) resulting from daily supplementation of 2.56 g of sodium (111 mmol), in addition to the food intake of a low-sodium diet from V2 to the end of the study (<5g of NaCl / day), for 7 days, either as sodium chloride or as sodium bicarbonate in hypertensive subjects.
This clinical trial will be separated in 2 phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure between 135-160 mmHg and diastolic 85-100 in self-measurement, untreated or treated but not balanced under treatment,
- •Father or mother hypertensive,
- •Weight ≥ 50 kg
- •Absence of known heart disease,
- •Brachialis perimeter between 22 and 42 cm,
- •Creatinine clearance within the standards dating from less than 12 months, (GFR> 60ml / min / 1.73m²),
- •Agreeing to drink sparkling water during one of the study periods,
- •Effective contraception for female subjects of childbearing age,
- •Cooperation and understanding sufficient to comply with the requirements of the test,
- •Affiliated with a Social Security scheme,
- •Agreeing to give written consent,
- •Registration or acceptance of registration in the national register of volunteers participating in research.
排除标准
- •Consumption of more than 5g/day of salt in the protocol diet (evaluated by natriuresis analyzed in V3)
- •Systemic corticosteroid therapy
- •Taking prohibited drugs (see list) and at the judgment of the investigator.
- •Suffering from pulmonary hypertension
- •Woman of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman,
- •History of cardiomyopathy or ischemic heart disease,
- •Absence of sinus rhythm,
- •Renal failure (DFG <60 ml/min/1.73m²),
- •Comorbidity incompatible with the study,
- •BMI> 35 kg/m2,
- •Disabling cognitive disorders,
- •Anxiety when taking measurements alone at home at the judgment of the investigator,
- •Diabetes (Type I and II)
- •Chronic alcoholism,
- •Sports activity deemed to be intense (more than 3 hours / week of intense sport),
- •Extreme sweating activity (Sauna, Hammam),
- •During participation in another clinical trial, or in the exclusion period, or having received a total amount of compensation greater than 4,500 euros over the 12 months preceding the start of the trial,
- •Benefiting from a legal protection measure (curatorship, guardianship, deprived of freedoms, safeguard of justice)
- •Not affiliated with the French Social Security scheme.
- •Any history deemed significant by the investigator.
结局指标
主要结局
Change from mean blood pressure (MBP) at Day 21
时间窗: Day 21
Comparison between blood pressure data recorded by the volunteer between the 2 weeks of treatment (measurement during 2 days before Day 7 and 2 days before Day 21). Recording of systolic and diastolic blood pressure will be made by the patient at home with the Microlife BP A200 device, in the morning and evening. Comparison of the data collected from these 2 weeks of treatment will allow us to meet the main objective of the study.
次要结局
- Change from mean blood pressure (MBP) at Day -7(Day -7)
- Weight(Day -28, Day -21, Day -14, Day -7, Day 7 and Day 21)
- Body composition analysis(Day -21, Day -14, Day -7, Day 7 and Day 21)
- Optional genotyping(One time at Day -28)
- Plasma renin dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma Angiotensin II dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma Aldosterone dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma potassium dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma sodium dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma calcium dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma chlorine dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Plasma protein dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Serum creatinine dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Serum urea dosage on fasted state(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Sodium concentration in 24h urine(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Potassium concentration in 24h urine(Day -28, Day -14, Day -7, Day 7 and Day 21)
- Creatinine concentration in 24h urine(Day -28, Day -14, Day -7, Day 7 and Day 21)