<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810885</url>
  </required_header>
  <id_info>
    <org_study_id>H-17030995</org_study_id>
    <nct_id>NCT03810885</nct_id>
  </id_info>
  <brief_title>SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread</brief_title>
  <acronym>STRIVE</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial is conducted as a randomized controlled trial including children and adults&#xD;
      recruited as families. The families are randomly allocated into three groups to investigate&#xD;
      the effect of different salt reduction strategies in a period of 3-4 months. Families in the&#xD;
      first intervention group are receiving salt reduced bread. Families in the second&#xD;
      intervention group are receiving salt reduced bread in combination with dietary counselling&#xD;
      to reduce salt and increase potassium intake. Families in the control group are receiving&#xD;
      bread with a regular content of salt and no dietary counselling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is conducted as a randomized controlled trial including children and adults&#xD;
      recruited as families. The families are randomly allocated into three groups to investigate&#xD;
      the effect of different salt reduction strategies in a period of 3-4 months. Families in the&#xD;
      first intervention group are receiving salt reduced bread. Families in the second&#xD;
      intervention group are receiving salt reduced bread in combination with dietary counselling&#xD;
      to reduce salt and increase potassium intake. Families in the control group are receiving&#xD;
      bread with a regular content of salt and no dietary counselling.&#xD;
&#xD;
      Participants will be instructed to replace their usual consumption of bread by the bread&#xD;
      products provided in the study. In all other respects, participants will be requested to live&#xD;
      their lives as usual without changing any habits, except the families receiving dietary&#xD;
      counselling. The participants will be unaware of the treatment groups and the salt content of&#xD;
      the bread products will be blinded to the participants.&#xD;
&#xD;
      Families will attend a physical examination at baseline and at 3-4 months follow-up. The&#xD;
      health examination includes anthropometrics, blood pressure measurements and blood samplings&#xD;
      for analysis of glucose, lipid metabolism and hormone balance. Urine samples will be&#xD;
      collected to investigate the sodium and potassium content. Furthermore salt-sensitivity and&#xD;
      preference tests will be made. After both health examinations the families will collect three&#xD;
      repeated 24-hour urine collections at home and fill in a 7 days dietary record.&#xD;
&#xD;
      After data collection, blood and urine samples will be analysed. Analyses from both baseline&#xD;
      and follow-up are expected ultimo February 2019, whereby data cleaning and statistical&#xD;
      analyses will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Active Comparator:&#xD;
Intervention A : Salt reduced bread&#xD;
Assigned Interventions: Participants will receive salt reduced bread and no dietary counselling.&#xD;
Active Comparator:&#xD;
Intervention A+B: Salt reduced bread + Dietary counselling&#xD;
Assigned Interventions: Participants in this group will receive both salt reduced bread and dietary counselling to reduce salt and increase potassium intake.&#xD;
Placebo comparator:&#xD;
Control: normal bread&#xD;
Assigned Interventions: Participants will receive bread with a regular content of salt and no dietary counselling.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participants will be unaware of the treatment groups and the salt content of the bread products will be blinded to the participants.&#xD;
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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline sodium level in 24 hour urine at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline potassium level in 24 hour urine at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Systolic blood pressure at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Diastolic blood pressure at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Renin and Aldosterone levels in plasma at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Salt sensitivity and preference at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Sensory test: Sensitivity and preference test, minimum 2 hours of fasting</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline Glucose levels in plasma at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline HbA1C levels in full blood at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Cholesterol levels in plasma (LDL, HDL, total cholesterol and triglycerides) at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Height in centimetres at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Measured in centimetres to the closest decimal, without shoes or socks, with clothes on</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Weight in kilograms at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Measured in kilograms to the closest decimal, without shoes or socks, with clothes on</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Impedance in ohm at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Measured in ohm to the closest decimal, without shoes or socks, with clothes on</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Hip circumference in centimetres at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Measured on bare skin to nearest decimal</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Waist circumference in centimetres at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Measured on bare skin to nearest decimal</description>
  </other_outcome>
  <other_outcome>
    <measure>Baseline Albumin in spot urine</measure>
    <time_frame>Measurements at Baseline</time_frame>
    <description>Not morning urine, minimum 2 hours of fasting</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline Sodium, potassium and creatinine level in spot urine at 4 months</measure>
    <time_frame>Measurements at Baseline and at 4 month.</time_frame>
    <description>Not morning urine, minimum 2 hours of fasting</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">316</enrollment>
  <condition>Salt Intake</condition>
  <arm_group>
    <arm_group_label>Salt reduced bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bread with reduced salt content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary advice and Salt reduced bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bread with reduced salt content, dietary advice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal bread</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Bread with standard salt content</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bread with reduced salt content</intervention_name>
    <description>Bread with gradually lowered salt content</description>
    <arm_group_label>Dietary advice and Salt reduced bread</arm_group_label>
    <arm_group_label>Salt reduced bread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary advice</intervention_name>
    <description>Participants will receive information on how to lower salt and increase potassium intake</description>
    <arm_group_label>Dietary advice and Salt reduced bread</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bread with standard salt content</intervention_name>
    <description>Bread with normal salt content</description>
    <arm_group_label>Normal bread</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants living with children&#xD;
&#xD;
          -  Adults 18-69 years&#xD;
&#xD;
          -  Children 3-17 years&#xD;
&#xD;
          -  Daily intake of bread&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Antihypertensive treatment&#xD;
&#xD;
          -  Lipid-lowering treatment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  U-albumin &gt; 300 mg/day&#xD;
&#xD;
          -  Celiac disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulla Toft, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Region, Copenhagen, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center fot Clinical Research and Prevention</name>
      <address>
        <city>Glostrup</city>
        <state>Capital Region</state>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Ulla Toft</investigator_full_name>
    <investigator_title>Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention</investigator_title>
  </responsible_party>
  <keyword>24hr urine collection</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03810885/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03810885/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810885
org study id: H-17030995
nct id: NCT03810885
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: 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.
primary purpose: Prevention
masking: Single (Participant)
masking description: 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.
measure: Change from Baseline sodium level in 24 hour urine at 4 months
time frame: Measurements at Baseline and at 4 month.
description: 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).
measure: Change from Baseline potassium level in 24 hour urine at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning.
measure: Change from Baseline Systolic blood pressure at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.
measure: Change from Baseline Diastolic blood pressure at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.
measure: Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months
time frame: Measurements at Baseline and at 4 month.
description: blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
measure: Change from Baseline Renin and Aldosterone levels in plasma at 4 months
time frame: Measurements at Baseline and at 4 month.
description: blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
measure: Change from Baseline Salt sensitivity and preference at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Sensory test: Sensitivity and preference test, minimum 2 hours of fasting
measure: Change from Baseline Glucose levels in plasma at 4 months
time frame: Measurements at Baseline and at 4 month.
description: blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
measure: Change from Baseline HbA1C levels in full blood at 4 months
time frame: Measurements at Baseline and at 4 month.
description: blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
measure: Change from Baseline Cholesterol levels in plasma (LDL, HDL, total cholesterol and triglycerides) at 4 months
time frame: Measurements at Baseline and at 4 month.
description: blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
measure: Change from Baseline Height in centimetres at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Measured in centimetres to the closest decimal, without shoes or socks, with clothes on
measure: Change from Baseline Weight in kilograms at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Measured in kilograms to the closest decimal, without shoes or socks, with clothes on
measure: Change from Baseline Impedance in ohm at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Measured in ohm to the closest decimal, without shoes or socks, with clothes on
measure: Change from Baseline Hip circumference in centimetres at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Measured on bare skin to nearest decimal
measure: Change from Baseline Waist circumference in centimetres at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Measured on bare skin to nearest decimal
measure: Baseline Albumin in spot urine
time frame: Measurements at Baseline
description: Not morning urine, minimum 2 hours of fasting
measure: Change from Baseline Sodium, potassium and creatinine level in spot urine at 4 months
time frame: Measurements at Baseline and at 4 month.
description: Not morning urine, minimum 2 hours of fasting
arm group label: Salt reduced bread
arm group type: Experimental
description: Bread with reduced salt content
arm group label: Dietary advice and Salt reduced bread
arm group type: Experimental
description: bread with reduced salt content, dietary advice
arm group label: Normal bread
arm group type: Placebo Comparator
description: Bread with standard salt content
intervention type: Other
intervention name: Bread with reduced salt content
description: Bread with gradually lowered salt content
arm group label: Dietary advice and Salt reduced bread
arm group label: Salt reduced bread
intervention type: Behavioral
intervention name: Dietary advice
description: Participants will receive information on how to lower salt and increase potassium intake
arm group label: Dietary advice and Salt reduced bread
intervention type: Other
intervention name: Bread with standard salt content
description: Bread with normal salt content
arm group label: Normal bread
criteria: 
gender: All
minimum age: 3 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ulla Toft, MSc, PhD
role: Principal Investigator
affiliation: Capital Region, Copenhagen, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Ulla Toft
investigator title: Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention
sharing ipd: No
provided document: 
provided document: 