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SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread (STRIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810885
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ulla Toft, Bispebjerg Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Salt Intake Other: Bread with reduced salt content Behavioral: Dietary advice Other: Bread with standard salt content Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
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.

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.

Primary Purpose: Prevention
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
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Salt reduced bread
Bread with reduced salt content
Other: Bread with reduced salt content
Bread with gradually lowered salt content

Experimental: Dietary advice and Salt reduced bread
bread with reduced salt content, dietary advice
Other: Bread with reduced salt content
Bread with gradually lowered salt content

Behavioral: Dietary advice
Participants will receive information on how to lower salt and increase potassium intake

Placebo Comparator: Normal bread
Bread with standard salt content
Other: Bread with standard salt content
Bread with normal salt content




Primary Outcome Measures :
  1. Change from Baseline sodium level in 24 hour urine at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    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).


Secondary Outcome Measures :
  1. Change from Baseline potassium level in 24 hour urine at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning.

  2. Change from Baseline Systolic blood pressure at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.

  3. Change from Baseline Diastolic blood pressure at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.

  4. Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.

  5. Change from Baseline Renin and Aldosterone levels in plasma at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.

  6. Change from Baseline Salt sensitivity and preference at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Sensory test: Sensitivity and preference test, minimum 2 hours of fasting


Other Outcome Measures:
  1. Change from Baseline Glucose levels in plasma at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.

  2. Change from Baseline HbA1C levels in full blood at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.

  3. 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. ]
    blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.

  4. Change from Baseline Height in centimetres at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Measured in centimetres to the closest decimal, without shoes or socks, with clothes on

  5. Change from Baseline Weight in kilograms at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Measured in kilograms to the closest decimal, without shoes or socks, with clothes on

  6. Change from Baseline Impedance in ohm at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Measured in ohm to the closest decimal, without shoes or socks, with clothes on

  7. Change from Baseline Hip circumference in centimetres at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Measured on bare skin to nearest decimal

  8. Change from Baseline Waist circumference in centimetres at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Measured on bare skin to nearest decimal

  9. Baseline Albumin in spot urine [ Time Frame: Measurements at Baseline ]
    Not morning urine, minimum 2 hours of fasting

  10. Change from Baseline Sodium, potassium and creatinine level in spot urine at 4 months [ Time Frame: Measurements at Baseline and at 4 month. ]
    Not morning urine, minimum 2 hours of fasting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants living with children
  • Adults 18-69 years
  • Children 3-17 years
  • Daily intake of bread

Exclusion Criteria:

  • Diabetes
  • Cardiovascular disease
  • Antihypertensive treatment
  • Lipid-lowering treatment
  • Pregnancy
  • U-albumin > 300 mg/day
  • Celiac disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810885


Locations
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Denmark
Center fot Clinical Research and Prevention
Glostrup, Capital Region, Denmark, 2600
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Ulla Toft, MSc, PhD Capital Region, Copenhagen, Denmark
  Study Documents (Full-Text)

Documents provided by Ulla Toft, Bispebjerg Hospital:
Study Protocol  [PDF] December 22, 2017
Statistical Analysis Plan  [PDF] November 30, 2018

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Responsible Party: Ulla Toft, Associate Professor, PhD, MSc, Head of Section of Health Promotion and Prevention, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03810885    
Other Study ID Numbers: H-17030995
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulla Toft, Bispebjerg Hospital:
24hr urine collection