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

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

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.

Study Overview

• Status: Completed
• Conditions: Salt Intake
• Intervention / Treatment: Other: Bread with reduced salt content; Behavioral: Dietary advice; Other: Bread with standard salt content

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.

• Study Type: Interventional
• Enrollment (Actual): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Glostrup, Capital Region, Denmark, 2600
      • Center fot Clinical Research and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 69 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salt reduced bread; Bread with reduced salt content	Other: Bread with reduced salt content; Bread with gradually lowered salt content
Experimental: Dietary advice and Salt reduced bread; bread with reduced salt content, dietary advice	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
Placebo Comparator: Normal bread; Bread with standard salt content	Other: Bread with standard salt content; Bread with normal salt content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline sodium level in 24 hour urine at 4 months	Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning. Completeness evaluated in adults by Para-Amino-Benzoic-Acid (PABA).	Measurements at Baseline and at 4 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline potassium level in 24 hour urine at 4 months	Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning.	Measurements at Baseline and at 4 month.
Change from Baseline Systolic blood pressure at 4 months	Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.	Measurements at Baseline and at 4 month.
Change from Baseline Diastolic blood pressure at 4 months	Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.	Measurements at Baseline and at 4 month.
Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months	blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.	Measurements at Baseline and at 4 month.
Change from Baseline Renin and Aldosterone levels in plasma at 4 months	blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.	Measurements at Baseline and at 4 month.
Change from Baseline Salt sensitivity and preference at 4 months	Sensory test: Sensitivity and preference test, minimum 2 hours of fasting	Measurements at Baseline and at 4 month.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Glucose levels in plasma at 4 months	blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.	Measurements at Baseline and at 4 month.
Change from Baseline HbA1C levels in full blood at 4 months	blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.	Measurements at Baseline and at 4 month.
Change from Baseline Cholesterol levels in plasma (LDL, HDL, total cholesterol and triglycerides) at 4 months	blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.	Measurements at Baseline and at 4 month.
Change from Baseline Height in centimetres at 4 months	Measured in centimetres to the closest decimal, without shoes or socks, with clothes on	Measurements at Baseline and at 4 month.
Change from Baseline Weight in kilograms at 4 months	Measured in kilograms to the closest decimal, without shoes or socks, with clothes on	Measurements at Baseline and at 4 month.
Change from Baseline Impedance in ohm at 4 months	Measured in ohm to the closest decimal, without shoes or socks, with clothes on	Measurements at Baseline and at 4 month.
Change from Baseline Hip circumference in centimetres at 4 months	Measured on bare skin to nearest decimal	Measurements at Baseline and at 4 month.
Change from Baseline Waist circumference in centimetres at 4 months	Measured on bare skin to nearest decimal	Measurements at Baseline and at 4 month.
Baseline Albumin in spot urine	Not morning urine, minimum 2 hours of fasting	Measurements at Baseline
Change from Baseline Sodium, potassium and creatinine level in spot urine at 4 months	Not morning urine, minimum 2 hours of fasting	Measurements at Baseline and at 4 month.

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Ulla Toft, MSc, PhD, Capital Region, Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: 24hr urine collection
• Other Study ID Numbers: H-17030995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No