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Completed

NCT Number: NCT03810885

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

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.

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Key information

Conditions

Salt Intake

Age range

3 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center fot Clinical Research and Prevention

Glostrup Municipality, Capital Region, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bread with reduced salt content

Other

Bread with gradually lowered salt content

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study 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

Acronym: STRIVE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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