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

Sponsors

Lead Sponsor: Bispebjerg Hospital

Source 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.

Overall Status Completed
Start Date February 1, 2018
Completion Date April 30, 2019
Primary Completion Date April 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline sodium level in 24 hour urine at 4 months Measurements at Baseline and at 4 month.
Secondary Outcome
Measure Time Frame
Change from Baseline potassium level in 24 hour urine at 4 months Measurements at Baseline and at 4 month.
Change from Baseline Systolic blood pressure at 4 months Measurements at Baseline and at 4 month.
Change from Baseline Diastolic blood pressure at 4 months Measurements at Baseline and at 4 month.
Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months Measurements at Baseline and at 4 month.
Change from Baseline Renin and Aldosterone levels in plasma at 4 months Measurements at Baseline and at 4 month.
Change from Baseline Salt sensitivity and preference at 4 months Measurements at Baseline and at 4 month.
Enrollment 316
Condition
Intervention

Intervention Type: Other

Intervention Name: Bread with reduced salt content

Description: Bread with gradually lowered salt content

Intervention Type: Behavioral

Intervention Name: Dietary advice

Description: Participants will receive information on how to lower salt and increase potassium intake

Arm Group Label: Dietary advice and Salt reduced bread

Intervention Type: Other

Intervention Name: Bread with standard salt content

Description: Bread with normal salt content

Arm Group Label: Normal bread

Eligibility

Criteria:

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

Gender: All

Minimum Age: 3 Years

Maximum Age: 69 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ulla Toft, MSc, PhD Principal Investigator Capital Region, Copenhagen, Denmark
Location
Facility: Center fot Clinical Research and Prevention
Location Countries

Denmark

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Bispebjerg Hospital

Investigator Full Name: Ulla Toft

Investigator Title: Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Salt reduced bread

Type: Experimental

Description: Bread with reduced salt content

Label: Dietary advice and Salt reduced bread

Type: Experimental

Description: bread with reduced salt content, dietary advice

Label: Normal bread

Type: Placebo Comparator

Description: Bread with standard salt content

Acronym STRIVE
Patient Data No
Study Design Info

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.

Primary Purpose: Prevention

Masking: Single (Participant)

Masking Description: The participants will be unaware of the treatment groups and the salt content of the bread products will be blinded to the participants. Nurses examining participants at baseline and follow-up will be unaware of which intervention group the families were randomized into. The primary outcome measures will be blinded to the outcome assessors.

Source: ClinicalTrials.gov