SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread
Condition: Salt Intake
Study type: Interventional

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.
    

Intervention name(s): Bread with reduced salt content; Dietary advice; Bread with standard salt content
Intervention type(s): Other; Behavioral; Other
Intervention description(s): Bread with gradually lowered salt content; Participants will receive information on how to lower salt and increase potassium intake; Bread with normal salt content
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention 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 (Participant)
Primary purpose: Prevention
Keywords: 24hr urine collection