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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salt reduced bread | Experimental | Bread with reduced salt content |
|
| Dietary advice and Salt reduced bread | Experimental | bread with reduced salt content, dietary advice |
|
| Normal bread | Placebo Comparator | Bread with standard salt content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bread with reduced salt content | Other | Bread with gradually lowered salt content |
|
| 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. |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulla Toft, MSc, PhD | Capital Region, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center fot Clinical Research and Prevention | Glostrup Municipality | Capital Region | 2600 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2017 | Dec 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2018 | Dec 4, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001939 | Bread |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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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.
| Dietary advice | Behavioral | Participants will receive information on how to lower salt and increase potassium intake |
|
| Bread with standard salt content | Other | Bread with normal salt content |
|
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. |
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. |
| D003625 |
| Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |