SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread

Study Overview
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Brief Summary
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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
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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.

Official Title
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SalT Reduction InterVEntion: Examination of the Metabolic, Behavioral and Health Consequences of Reducing Salt Intake. A Randomized Controlled Trial in a Real Life Setting

Conditions
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Salt Intake

Intervention / Treatment
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* Other: Bread with reduced salt content
* Behavioral: Dietary advice
* Other: Bread with standard salt content


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants living with children Adults 18-69 years Children 3-17 years Daily intake of bread Exclusion Criteria: Diabetes Cardiovascular disease Antihypertensive treatment Lipid-lowering treatment Pregnancy U-albumin > 300 mg/day Celiac disease

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Active Comparator: Intervention A : Salt reduced bread Assigned Interventions: Participants will receive salt reduced bread and no dietary counselling. Active Comparator: Intervention A+B: Salt reduced bread + Dietary counselling Assigned Interventions: Participants in this group will receive both salt reduced bread and dietary counselling to reduce salt and increase potassium intake. Placebo comparator: Control: normal bread Assigned Interventions: Participants will receive bread with a regular content of salt and no dietary counselling.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salt reduced bread<br>Bread with reduced salt content | Other: Bread with reduced salt content<br>* Bread with gradually lowered salt content<br>|
| Experimental: Dietary advice and Salt reduced bread<br>bread with reduced salt content, dietary advice | Other: Bread with reduced salt content<br>* Bread with gradually lowered salt content<br>Behavioral: Dietary advice<br>* Participants will receive information on how to lower salt and increase potassium intake<br>|
| Placebo Comparator: Normal bread<br>Bread with standard salt content | Other: Bread with standard salt content<br>* Bread with normal salt content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline sodium level in 24 hour urine at 4 months | 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). | Measurements at Baseline and at 4 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline potassium level in 24 hour urine at 4 months | Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning. | Measurements at Baseline and at 4 month. | 
| Change from Baseline Systolic blood pressure at 4 months | Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting. | Measurements at Baseline and at 4 month. | 
| Change from Baseline Diastolic blood pressure at 4 months | Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting. | Measurements at Baseline and at 4 month. | 
| Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months | blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting. | Measurements at Baseline and at 4 month. | 
| Change from Baseline Renin and Aldosterone levels in plasma at 4 months | blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting. | Measurements at Baseline and at 4 month. | 
| Change from Baseline Salt sensitivity and preference at 4 months | Sensory test: Sensitivity and preference test, minimum 2 hours of fasting | Measurements at Baseline and at 4 month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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24hr urine collection