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

Bispebjerg Hospital

Status: Completed

Conditions: Salt Intake

Treatments: Behavioral: Dietary advice; Other: Bread with standard salt content; Other: Bread with reduced salt content

Study type: Interventional

Funder types: Other

Identifiers

NCT03810885

H-17030995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 patients

Sex: All

Ages: 3 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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316 participants in 3 patient groups, including a placebo group

Salt reduced bread

Experimental group

Description:

Bread with reduced salt content

Treatment:

Other: Bread with reduced salt content

Dietary advice and Salt reduced bread

Experimental group

Description:

bread with reduced salt content, dietary advice

Treatment:

Behavioral: Dietary advice

Other: Bread with reduced salt content

Normal bread

Placebo Comparator group

Description:

Bread with standard salt content

Treatment:

Other: Bread with standard salt content