NCT03810885

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Salt Intake

Interventions

Type	Name	Description
OTHER	Bread with reduced salt content	Bread with gradually lowered salt content
BEHAVIORAL	Dietary advice	Participants will receive information on how to lower salt and increase potassium intake
OTHER	Bread with standard salt content	Bread with normal salt content

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2019-01-22
• Last updated: 2019-07-12

Locations

1 site across 1 country: Denmark