Salt IntakeSTRIVENCT03810885
SalT Reduction InterVEntion: Metabolic, Behavioral and Health Consequences of Reducing Salt in Bread
A study testing Bread with reduced salt content, Dietary advice and Bread with standard salt content in people with Salt Intake, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt Intake
- What is being tested?
- Bread with reduced salt content, Dietary advice and Bread with standard salt content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants living with children
- Adults 18-69 years
- Children 3-17 years
- Daily intake of bread
Who cannot join
- Diabetes
- Cardiovascular disease
- Antihypertensive treatment
- Lipid-lowering treatment
- Pregnancy
- U-albumin > 300 mg/day
- Celiac disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center fot Clinical Research and Prevention
Glostrup Municipality, Capital Region, 2600
About this study
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
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.
Read the 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.
- Conditions
- Salt Intake
- Being tested
- Bread with reduced salt content, Dietary advice, Bread with standard salt content
- Keywords
- 24hr urine collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread with reduced salt contentOther
Bread with gradually lowered salt content
Dietary adviceBehavioural
Participants will receive information on how to lower salt and increase potassium intake
Bread with standard salt contentOther
Bread with normal salt content
| Study group | Role | What they receive |
|---|---|---|
| Salt reduced bread | Experimental | Bread with reduced salt content Receives: Other: Bread with reduced salt content |
| Dietary advice and Salt reduced bread | Experimental | bread with reduced salt content, dietary advice Receives: Other: Bread with reduced salt content; Behavioral: Dietary advice |
| Normal bread | Placebo comparator | Bread with standard salt content Receives: Other: Bread with standard salt content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline sodium level in 24 hour urine at 4 months
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).
Measured: Measurements at Baseline and at 4 month.
Secondary outcomes (6)
Change from Baseline potassium level in 24 hour urine at 4 months
Adults average of 3 repeated 24 hour urine, children a single 24hour urine collection; excluding urine first morning including urine of the following morning.
Measured: Measurements at Baseline and at 4 month.
Change from Baseline Systolic blood pressure at 4 months
Systolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.
Measured: Measurements at Baseline and at 4 month.
Change from Baseline Diastolic blood pressure at 4 months
Diastolic blood pressure measured at baseline and follow-up . Average of three measurements, with the participant sitting upright at rest.. Minimum 2 hours fasting.
Measured: Measurements at Baseline and at 4 month.
Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months
blood sampled, stored on ice, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
Measured: Measurements at Baseline and at 4 month.
Change from Baseline Renin and Aldosterone levels in plasma at 4 months
blood sampled, with the participant lying down after 30 minutes of rest. Minimum 2 hours of fasting.
Measured: Measurements at Baseline and at 4 month.
Change from Baseline Salt sensitivity and preference at 4 months
Sensory test: Sensitivity and preference test, minimum 2 hours of fasting
Measured: Measurements at Baseline and at 4 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Feb 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Toft, Bispebjerg Hospital
- Investigators
- Ulla Toft, MSc, PhD, Principal investigator, Capital Region, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810885
- Sponsor's protocol ID
- H-17030995
- Acronym
- STRIVE
- Status last verified
- Jul 2019
- First submitted
- 30 Nov 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03810885
- Acronym / sponsor ID
- STRIVE / H-17030995
- Conditions
- Salt Intake
- Keywords
- 24hr urine collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Salt reduced bread | Experimental | Other: Bread with reduced salt contentBread with reduced salt content |
| Dietary advice and Salt reduced bread | Experimental | Other: Bread with reduced salt content, Behavioral: Dietary advicebread with reduced salt content, dietary advice |
| Normal bread | Placebo comparator | Other: Bread with standard salt contentBread with standard salt content |
Who may qualify
- Ages
- 3 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants living with children
- Adults 18-69 years
- Children 3-17 years
- Daily intake of bread
Key exclusion criteria (7 listed)
- Diabetes
- Cardiovascular disease
- Antihypertensive treatment
- Lipid-lowering treatment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bread with reduced salt contentBread with gradually lowered salt content | Other | Dietary advice and Salt reduced bread, Salt reduced bread |
| Dietary adviceParticipants will receive information on how to lower salt and increase potassium intake | Behavioural | Dietary advice and Salt reduced bread |
| Bread with standard salt contentBread with normal salt content | Other | Normal bread |
Primary outcome
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).
6 secondary outcomes
Change from Baseline potassium level in 24 hour urine at 4 months
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Systolic blood pressure at 4 months
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Diastolic blood pressure at 4 months
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Adrenaline and Noradrenaline levels in plasma at 4 months
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Renin and Aldosterone levels in plasma at 4 months
Time frame: Measurements at Baseline and at 4 month.
Change from Baseline Salt sensitivity and preference at 4 months
Time frame: Measurements at Baseline and at 4 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Toft, MSc, PhD principal investigator
Capital Region, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread with reduced salt content, Dietary advice and Bread with standard salt content in people with Salt Intake, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline sodium level in 24 hour urine at 4 months (time frame: Measurements at Baseline and at 4 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.