Clinical trial NCT03810885: SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread
Official title: SalT Reduction InterVEntion: Examination of the Metabolic, Behavioral and Health Consequences of Reducing Salt Intake. A Randomized Controlled Trial in a Real Life Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Salt Intake
Keywords: 24hr urine collection
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 316
Sex: ALL
Minimum age (years): 3
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

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.

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

Primary outcomes:
measure: Change from Baseline sodium level in 24 hour urine at 4 months
timeFrame: Measurements at Baseline and at 4 month.
Secondary outcomes:
measure: Change from Baseline potassium level in 24 hour urine at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Systolic blood pressure at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Diastolic blood pressure at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Renin and Aldosterone levels in plasma at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Salt sensitivity and preference at 4 months
timeFrame: Measurements at Baseline and at 4 month.
Other outcomes:
measure: Change from Baseline Glucose levels in plasma at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline HbA1C levels in full blood at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Cholesterol levels in plasma (LDL, HDL, total cholesterol and triglycerides) at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Height in centimetres at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Weight in kilograms at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Impedance in ohm at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Hip circumference in centimetres at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Change from Baseline Waist circumference in centimetres at 4 months
timeFrame: Measurements at Baseline and at 4 month.
measure: Baseline Albumin in spot urine
timeFrame: Measurements at Baseline
measure: Change from Baseline Sodium, potassium and creatinine level in spot urine at 4 months
timeFrame: Measurements at Baseline and at 4 month.
Locations:
city: Glostrup
country: Denmark
facility: Center fot Clinical Research and Prevention
state: Capital Region
Study officials:
affiliation: Capital Region, Copenhagen, Denmark
name: Ulla Toft, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: