SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread
NCT ID: NCT03810885
Last Updated: 2019-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
316 participants
INTERVENTIONAL
2018-02-01
2019-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
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.
PREVENTION
SINGLE
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.
Study Groups
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Salt reduced bread
Bread with reduced salt content
Bread with reduced salt content
Bread with gradually lowered salt content
Dietary advice and Salt reduced bread
bread with reduced salt content, dietary advice
Bread with reduced salt content
Bread with gradually lowered salt content
Dietary advice
Participants will receive information on how to lower salt and increase potassium intake
Normal bread
Bread with standard salt content
Bread with standard salt content
Bread with normal salt content
Interventions
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Bread with reduced salt content
Bread with gradually lowered salt content
Dietary advice
Participants will receive information on how to lower salt and increase potassium intake
Bread with standard salt content
Bread with normal salt content
Eligibility Criteria
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Inclusion Criteria
* Adults 18-69 years
* Children 3-17 years
* Daily intake of bread
Exclusion Criteria
* Cardiovascular disease
* Antihypertensive treatment
* Lipid-lowering treatment
* Pregnancy
* U-albumin \> 300 mg/day
* Celiac disease
3 Years
69 Years
ALL
Yes
Sponsors
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Bispebjerg Hospital
OTHER
Responsible Party
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Ulla Toft
Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention
Principal Investigators
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Ulla Toft, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Capital Region, Copenhagen, Denmark
Locations
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Center fot Clinical Research and Prevention
Glostrup Municipality, Capital Region, Denmark
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H-17030995
Identifier Type: -
Identifier Source: org_study_id
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