An interventional study of Bread with reduced salt content and Dietary advice in Salt Intake, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 3 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Prevention
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.
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.
Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bread with reduced salt content
Other: Bread with reduced salt content
bread with reduced salt content, dietary advice
Other: Bread with reduced salt content · Behavioral: Dietary advice
Bread with standard salt content
Other: Bread with standard salt content
Bread with gradually lowered salt content
Participants will receive information on how to lower salt and increase potassium intake
Bread with normal salt content
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).
Time frame: Measurements at Baseline and at 4 month.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Measurements at Baseline and at 4 month.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Hip circumference in centimetres at 4 months
Measured on bare skin to nearest decimal
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Waist circumference in centimetres at 4 months
Measured on bare skin to nearest decimal
Time frame: Measurements at Baseline and at 4 month.
Baseline Albumin in spot urine
Not morning urine, minimum 2 hours of fasting
Time frame: 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
Time frame: Measurements at Baseline and at 4 month.
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Plan to share: No
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Bispebjerg Hospital