SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread
- Conditions
- Salt Intake
- Interventions
- Other: Bread with reduced salt contentOther: Bread with standard salt contentBehavioral: Dietary advice
- Registration Number
- NCT03810885
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- Participants living with children
- Adults 18-69 years
- Children 3-17 years
- Daily intake of bread
- Diabetes
- Cardiovascular disease
- Antihypertensive treatment
- Lipid-lowering treatment
- Pregnancy
- U-albumin > 300 mg/day
- Celiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Dietary advice and Salt reduced bread Bread with reduced salt content bread with reduced salt content, dietary advice Dietary advice and Salt reduced bread Dietary advice bread with reduced salt content, dietary advice Salt reduced bread Bread with reduced salt content Bread with reduced salt content Normal bread Bread with standard salt content Bread with standard salt content
- Primary Outcome Measures
Name Time Method Change from Baseline sodium level in 24 hour urine at 4 months 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).
- Secondary Outcome Measures
Name Time Method Change from Baseline Salt sensitivity and preference at 4 months Measurements at Baseline and at 4 month. Sensory test: Sensitivity and preference test, minimum 2 hours of fasting
Change from Baseline Systolic blood pressure at 4 months Measurements at Baseline and at 4 month. Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.
Change from Baseline Diastolic blood pressure at 4 months Measurements at Baseline and at 4 month. Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.
Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months Measurements at Baseline and at 4 month. blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
Change from Baseline potassium level in 24 hour urine at 4 months 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.
Change from Baseline Renin and Aldosterone levels in plasma at 4 months Measurements at Baseline and at 4 month. blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
Trial Locations
- Locations (1)
Center fot Clinical Research and Prevention
🇩🇰Glostrup, Capital Region, Denmark