Effectiveness of Low-salt Bread on the Total Sodium Intake in Patients With Chronic Heart Failure and Chronic Kidney Disease (LoSa Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sodium excretion urine
研究概览
简要总结
SUMMARY Rationale Patients with heart failure may suffer from a poor quality of life (QoL) due to frequent hospital admittance, medication intake, and symptoms as a result of progression of their disease. The general salt intake in the Dutch population is too high, leading indirectly to hypertension resulting in worsening of cardiovascular disease such as heart failure. Patients with heart failure are highly salt sensitive. A quarter of the daily salt intake originates from bread. Salt restriction is difficult to maintain.
The aim of this study is to lower the daily salt intake by providing a palatable low salt bread to patients with heart failure. This may lead to a stable disease and therefore an improvement in quality of life.
Objective The aim of this study is to investigate whether substitution of normal bread by a new palatable form of low salt bread is effective in reducing salt intake in patients with chronic heart failure. The investigators will evaluate the effectiveness, the compliance and the outcome of the presumed salt reduction.
Study design This is a single center, randomized, double blinded, cross-over trial with a follow-up period of twelve weeks performed in VieCuri, Medical Centre in Venlo.
Study population In this study, 20 patients visiting the outpatient clinic with heart failure NYHA class 3-4 will be included. All patients are 18 years or older.
Intervention Given the study design all 20 patients receive a low salt bread (0.05 gram sodium per slice) for one period and received bread with a normal amount of sodium (0.35 gram sodium per slice) in the other period. After six weeks follow up, the groups change the intervention.
Main study parameters/endpoints The investigators expect a reduction of daily salt intake of 1.5 gram sodium by an average of 5 slices bread a day.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness Patients should visit the hospital three times. Prior the hospital visit they have to collect 24- hour urine. During all visits blood samples will be taken and a physical exam is performed. Also blood pressure will be measured. Most of these parameters are also collected for clinical purposes. Patients should at the same time report their daily intake in a personal food diary and fill in questionnaires about their opinion of the bread and quality of life.
详细描述
The study population is randomized and participants are chosen based on the diagnosis of chronic heart failure. After participants were informed and consented by telephone and in writing, secondary data were collected (primary etiology of disease, age, height, weight, BMI, medication). Patients were randomized and the study bread was prepared by a baker. Only the baker was aware of which bread was the normal bread and which was the study bread. Both loaves were labeled. Participants, investigators and outcome assessors were blinded to the assignment.
The study was a crossover study. The participants were followed for a period of 12 weeks, during which they took 6 weeks of low-salt bread and 6 weeks of normal bread. A minimum intake of 4-5 slices of bread per day was requested for participation in the study. Two different loaves were made; a loaf with 0.35 grams of salt per slice of bread (normal) and a loaf with 0.05 grams of salt per slice of bread (low salt content). Based on an average bread intake of 4-5 slices per day, a clinically relevant difference in sodium excretion between the interventions of 1.2-1.5 grams per day was expected. Patients were informed by telephone and in writing about the need to eat at least 4 slices of bread per day. It was expressly stated that if the patient could not achieve this, participation was not possible.
These intervention groups are thus as follows:
- Group 1: starts with the Scelta bread with a normal amount of sodium (0.4 grams sodium per slice)
- Group 2: starts with the low sodium Scelta bread (0.1 gram sodium per slice). During this period, the subjects kept a food diary 1 day per week (12 days in total).
At three different times there were contact moments (45 minutes) with the patient and data were collected consisting of: 15 minutes blood pressure measurement, collection of 24-hour urine, body weight and bioimpedance measurement, a short physical examination, filling in questionnaire about quality of life and nutrition and finally a blood test. The included patients were also seen by the dietitian immediately after contact with the researcher. They also received dietary advice regarding salt restriction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Age at least 18 years;
- •CHF NYHA III-IV or LVEF <35%, stable condition on optimal medical therapy: no medication changes in last two weeks prior to start study.
- •Written informed consent
- •Speak and read Dutch
排除标准
- •Pregnancy or breastfeeding
- •Participating in any other interventional research study during the same period
- •Hyponatremia; sodium < 130 mmol/L
- •Hypokaliemia < 3.4 mmol/l
- •Hyperkaliemia > 5.5 mmol/l
- •Cognitive impairment
- •Blood pressure systolic below 100 mmHg OR diastolic below 50 mmHg
- •Allergic reaction to mushrooms, silica, corn and gluten
- •Life expectancy shorter than one year
结局指标
主要结局
Sodium excretion urine
时间窗: 6 weeks
24-hour urine sample will be analysed on sodium excretion. This will be measured at baseline and after each 6 week period. Also sodium, protein, albumin and creatinine concentration will be measured.
次要结局
- Sodium intake(12 weeks.)
- Taste of bread(6 weeks)
- Quality of Life Questionnaire(6 weeks)
- Blood pressure(6 weeks)
- Blood samples(6 weeks)
- Body composition measurement with bioimpedance spectroscopy (BIS)(6 weeks)