SalT Reduction InterVEntion: Examination of the Metabolic, Behavioral and Health Consequences of Reducing Salt Intake. A Randomized Controlled Trial in a Real Life Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change from Baseline sodium level in 24 hour urine at 4 months
研究概览
简要总结
The trial is conducted as a randomized controlled trial including children and adults recruited as families. The families are randomly allocated into three groups to investigate the effect of different salt reduction strategies in a period of 3-4 months. Families in the first intervention group are receiving salt reduced bread. Families in the second intervention group are receiving salt reduced bread in combination with dietary counselling to reduce salt and increase potassium intake. Families in the control group are receiving bread with a regular content of salt and no dietary counselling.
详细描述
The trial is conducted as a randomized controlled trial including children and adults recruited as families. The families are randomly allocated into three groups to investigate the effect of different salt reduction strategies in a period of 3-4 months. Families in the first intervention group are receiving salt reduced bread. Families in the second intervention group are receiving salt reduced bread in combination with dietary counselling to reduce salt and increase potassium intake. Families in the control group are receiving bread with a regular content of salt and no dietary counselling.
Participants will be instructed to replace their usual consumption of bread by the bread products provided in the study. In all other respects, participants will be requested to live their lives as usual without changing any habits, except the families receiving dietary counselling. The participants will be unaware of the treatment groups and the salt content of the bread products will be blinded to the participants.
Families will attend a physical examination at baseline and at 3-4 months follow-up. The health examination includes anthropometrics, blood pressure measurements and blood samplings for analysis of glucose, lipid metabolism and hormone balance. Urine samples will be collected to investigate the sodium and potassium content. Furthermore salt-sensitivity and preference tests will be made. After both health examinations the families will collect three repeated 24-hour urine collections at home and fill in a 7 days dietary record.
After data collection, blood and urine samples will be analysed. Analyses from both baseline and follow-up are expected ultimo February 2019, whereby data cleaning and statistical analyses will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The participants will be unaware of the treatment groups and the salt content of the bread products will be blinded to the participants.
Nurses examining participants at baseline and follow-up will be unaware of which intervention group the families were randomized into. The primary outcome measures will be blinded to the outcome assessors.
入排标准
- 年龄范围
- 3 Years 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants living with children
- •Adults 18-69 years
- •Children 3-17 years
- •Daily intake of bread
排除标准
- •Cardiovascular disease
- •Antihypertensive treatment
- •Lipid-lowering treatment
- •Pregnancy
- •U-albumin > 300 mg/day
- •Celiac disease
研究组 & 干预措施
Salt reduced bread
Bread with reduced salt content
干预措施: Bread with reduced salt content (Other)
Dietary advice and Salt reduced bread
bread with reduced salt content, dietary advice
干预措施: Bread with reduced salt content (Other)
Dietary advice and Salt reduced bread
bread with reduced salt content, dietary advice
干预措施: Dietary advice (Behavioral)
Normal bread
Bread with standard salt content
干预措施: Bread with standard salt content (Other)
结局指标
主要结局
Change from Baseline sodium level in 24 hour urine at 4 months
时间窗: Measurements at Baseline and at 4 month.
Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning. Completeness evaluated in adults by Para-Amino-Benzoic-Acid (PABA).
次要结局
- Change from Baseline Salt sensitivity and preference at 4 months(Measurements at Baseline and at 4 month.)
- Change from Baseline Systolic blood pressure at 4 months(Measurements at Baseline and at 4 month.)
- Change from Baseline Diastolic blood pressure at 4 months(Measurements at Baseline and at 4 month.)
- Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months(Measurements at Baseline and at 4 month.)
- Change from Baseline potassium level in 24 hour urine at 4 months(Measurements at Baseline and at 4 month.)
- Change from Baseline Renin and Aldosterone levels in plasma at 4 months(Measurements at Baseline and at 4 month.)
研究者
Ulla Toft
Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention
Bispebjerg Hospital