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. 2019 Sep 21;16(19):3532. doi: 10.3390/ijerph16193532

Table A1.

Trial registration data.

Data Category Information
Primary registry and trial identification number Clinical Trials.gov: NCT03810885
Date of registration in primary registry January 2019
Secondary identifying numbers The Ethics Committee of the Capital Region of Denmark:H-17030995
The Danish Data Protection Agency: CSU-FCFS-2017-017
Source(s) of monetary or material support The Danish Heart Foundation, The Research Fond of the Capital Region of Denmark, The Toyota Foundation, Ministry of Environment and Food of Denmark, Axel Muusfeldt’s Foundation and Sofus Friis’ Foundation and the Technical University of Denmark
Primary sponsor The Danish Heart Foundation
Secondary sponsor(s) The Research Fond of the Capital Region of Denmark, The Toyota Foundation, Ministry of Environment and Food of Denmark, Axel Muusfeldt’s Foundation and Sofus Friis’ Foundation and the Technical University of Denmark
Contact for public queries MSc, PhD kirsten.bjoernsbo@regionh.dk
Contact for scientific queries MSc, PhD ulla.toft@regionh.dk
Public title Saltintervention: Bread and Health
Scientific title SalT Reduction InterVEntion (STRIVE): Examination of the Metabolic, Behavioral and Health Consequences of Reducing Salt Intake. A Randomized Controlled Trial in a Real Life Setting
Country of recruitment Denmark
Health condition(s) or problems studied Salt intake
Intervention(s) Salt reduced bread
Salt reduced bread + Dietary Counselling
Control: Normal bread
Key inclusion and exclusion criteria Inclusion Criteria:

  • Participants living with children

  • Adults 18–69 years

  • Children 3–17 years

  • Daily intake of bread (adults 175 g per day)

  • Exclusion Criteria:

  • Diabetes

  • Cardiovascular disease

  • Antihypertensive treatment

  • Lipid-lowering treatment

  • Pregnancy

  • U-albumin >300 mg/day

  • Celiac disease
Study type Interventional
Allocation: Randomized
Blinding: Blinded to participants and outcome assessors
Data of first enrollment February 2018
Target sample size 120 families
Recruitment status 96 families
Primary outcome(s) Change from Baseline sodium level in 24 h urine at 4 months (follow-up)
Key secondary outcomes Change from baseline levels regarding BP, Blood lipids, potassium, Na/K ratio, salt sensitivity and preference, dietary intake