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临床试验/NCT06651437
NCT06651437已完成不适用

A Nutritional Questionnaire in an Adult Italian Hypertensive Population: Effects on Sodium and Potassium Intake (MINISAL-SIIA STUDY)

Prof. Ferruccio Galletti0 个研究点目标入组 315 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
315
主要终点
Urinary Sodium and Potassium excretion (mmol/24h)

研究概览

简要总结

A strong and well-known association exists between salt consumption, potassium intake, and cardiovascular diseases. MINISAL-SIIA results showed high salt and low potassium consumption in Italian hypertensive patients. In addition, a recent Italian survey showed that the degree of knowledge and behavior about salt was directly interrelated, suggesting a key role of the educational approach. Therefore, the present study will aim to evaluate the efficacy of a short-time dietary educational intervention (MINIMAL-ADVICE) on sodium and potassium intake in hypertensive patients.

详细描述

High salt consumption is an important determinant of high blood pressure (BP) and cardiovascular diseases. Several intervention studies showed that a reduction in salt consumption reduces BP and can reduce cardiovascular risk beyond the beneficial effect on BP in people with and without hypertension. The World Health Organization (WHO) recommends that adults should consume no more than 5 g of salt daily. However, the mean daily intake of salt in the majority of countries worldwide exceeds this recommendation. In contrast to salt, epidemiological and intervention studies suggest beneficial effects of dietary potassium on BP and cardiovascular risk. This effect seems more pronounced during high salt consumption. The WHO currently also recommends that adults should consume not less than 90 mmol of potassium daily. However, also for potassium the WHO recommendations are not generally met.

Several countries have made some progress towards reducing habitual salt intake through a voluntary or regulatory approach, achieving a reduction of BP and cardiovascular disease in the young population. Our previous observational data detected that Italian general population samples consumed high dietary salt and low dietary potassium, far from the WHO guidelines recommendation. Excess dietary salt intake in the hypertensive patients' population was observed in all age categories and there were no differences in salt intake among different regions. Likewise, in the same hypertensive population the adequate potassium intake in both men and women, in all age categories, and in all the regions surveyed was much below the recommendation. These results point out the potential target to improve BP and cardiovascular risk, in particular in hypertensive patients. An Italian survey of a large cohort of the general population showed that the degree of knowledge and behaviour about salt was directly interrelated. These data suggested that educational approach is crucial to improve the level of salt consumption. The reduction of salt intake has been recommended by WHO as a cost-effective action that should be undertaken. Hence, an intervention study targeted to reduce dietary salt intake and also to increase dietary potassium consumption by an educational intervention is needed.

Given these premises, the aim of the present intervention study will be to evaluate the effect of a brief educational intervention "MINIMAL-ADVICE" for improving dietary salt and potassium intake in a hypertensive population. In addition, the effect of the educational intervention on BP in relation to the potential variation of salt and potassium intake will be also evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, 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

  • •Adult hypertensive patients with essential hypertension
  • •assessment of organ damage
  • •and stable antihypertensive treatment (lifestyle modifications and/or drug therapy) for at least 6 months

排除标准

  • •patients with alteration in nutritional and absorptive status
  • •glomerular filtration rate lower than 60 ml/min/1.73 m2
  • •personal history positive for a recent cardiovascular event (less than 6 months)
  • •atrial fibrillation or flutter, frequent atrial or ventricular premature contractions

研究组 & 干预措施

Control

No Intervention

the Control group will not receive any additional information on diet

Dietary educational intervention

Experimental

The dietary educational intervention group received dietary education to gradually reduce salt intake (a brief dietary education on the health damage due to excess salt consumption and on behavioural methods to gradually reduce dietary intake, for example at home, reduce the consumption of processed foods, do not bring salt shaker on the table, limit the use of condiments with a high sodium content; out of home, both when eating and when shopping, reduce the consumption of processed foods, check nutritional labels and choose products with lower salt content). In addition, written information was provided.

干预措施: Experimental dietary educational intervention (Other)

结局指标

主要结局

Urinary Sodium and Potassium excretion (mmol/24h)

时间窗: 3 months

Urinary sodium and potassium concentrations (mmol/24h) were measured by ion selective electrode potentiometry and urinary creatinine by a kinetic Jaffe reaction using an ABX Pentra 400 apparatus (HORIBA ABX, Rome, Italy). Quality control was effected using urine-specific reference samples from UrichemGol BIODEV (Milan, Italy).

次要结局

  • Systolic and Diastolic Blood Pressure (mmHg)(3 months)

研究者

发起方
Prof. Ferruccio Galletti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Ferruccio Galletti

Principal investigator

Federico II University

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