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

Salt Intake Clinical Trial

— STRIVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810885
• Other study ID #: H-17030995
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Salt Intake

Intervention

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

Locations

Country	Name	City	State
Denmark	Center fot Clinical Research and Prevention	Glostrup	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	Change from Baseline Hip circumference in centimetres at 4 months	Measured on bare skin to nearest decimal	Measurements at Baseline and at 4 month.
Other	Change from Baseline Waist circumference in centimetres at 4 months	Measured on bare skin to nearest decimal	Measurements at Baseline and at 4 month.
Other	Baseline Albumin in spot urine	Not morning urine, minimum 2 hours of fasting	Measurements at Baseline
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.