Elevated Blood PressureSaltbreadsNCT04003597
'Low-salt' Bread as a Means of Reducing Dietary Salt and Lowering Blood Pressure
A study testing Usual-salt diet and Reduced-salt diet in people with Elevated Blood Pressure, run by University College Cork at 1 site in Ireland.
Trial summary
In the context of public health, reformulation of bread in terms of salt content remains an important measure to help achieve a reduction in salt intake in the population. Therefore, the aim of this study was to examine, using a 5-week cross-over design, food-based intervention trial, the potential for inclusion of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure
- What is being tested?
- Usual-salt diet and Reduced-salt diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteIreland
- Study dates
- 3 Jan 2008to 30 Jul 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consenting adult Caucasian men and women, aged ≤65 y;
- a seated office systolic BP >120 and <160 mmHg and/or a diastolic BP >80 and <95 mmHg (based on the mean BP across 3 screening visits as part of a pre-intervention phase of the trial)
- willing to consume study breads
Who cannot join
- taking anti-hypertensive medication;
- taking any medications known to interfere with blood pressure or calcium or bone metabolism;
- Severe medical illness;
- celiac disease;
- hypercalcemia;
- known intestinal malabsorption syndrome,
- excessive alcohol use (>14 drinks/week);
- pregnancy
Trial locations and contacts
1 site in 1 country.
Ireland1 site
School of Food and Nutritional Sciences, University College Cork
Cork
About this study
Official title: 'Low-salt' Bread as Part of a Pragmatic Reduced-salt Diet for Lowering Blood Pressure in Adults With Elevated Blood Pressure
In the context of public health, reformulation of bread in terms of salt content remains an important measure to help achieve a reduction in salt intake in the population. Therefore, the aim of this study was to examine, using a 5-week cross-over design, food-based intervention trial, the potential for inclusion of 'low-salt' bread as part of a pragmatic reduced-salt diet on blood pressure (BP) in adults with slightly to moderately elevated BP.
The study consisted of a randomized crossover trial of the effect of reduced-salt intake or usual-salt intake for 5 weeks on BP (as the primary outcome) in adults with slightly to moderately elevated BP (seated office systolic BP >120 and <160 mmHg or a diastolic BP >80 and <95 mmHg; identified by a pre-screening phase).
Read more
Subjects were randomly assigned to the reduced-salt diet or their usual-salt diet (control) for 5 weeks, followed by crossover to the alternative dietary regimen for a further 5 weeks. Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt, if desired (optional); these were supplied regularly by the research staff. Subjects commencing the trial on the control diet were allowed to follow their usual diet but were asked to consume an in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g).
Participants met the research staff weekly to receive breads and no-salt margarine/butter as well as luncheon meats (where applicable), and at these meetings the staff promoted compliance with the intervention and encouraged completion of the study protocol.
BP and other assessments were made at baseline and at the end of week 5 and week 10.
Read the detailed description
Brief background and context for the study:
The World Health Organization's Global Action Plan for the Prevention and Control of Non-Communicable Disease includes a voluntary global target of a 30% relative reduction in mean population intake of salt/sodium by 2025. Bread and cured/processed meats collectively contribute anything from about a third upwards of total salt intake of adults in many Western countries. Reformulation of bread in terms of salt content remains an important measure to help achieve a reduction in salt intake in the population. Therefore, the aim of this study was to examine, using a 5-week cross-over design, food-based intervention trial, the potential for inclusion of 'low-salt' bread as part of a pragmatic reduced-salt diet on blood pressure (BP) in adults with slightly to moderately elevated BP.
Design:
The study consisted of a randomized crossover trial of the effect of reduced-salt intake or usual-salt intake for 5 weeks on BP (primary outcome) and biochemical markers of calcium and bone metabolism as well as plasma lipids (secondary outcomes) in adults with slightly to moderately elevated BP.
Potential volunteers were screened for BP over 3 weeks preceding the intervention phase of the trial during which seated office systolic and diastolic BP were measured weekly and those with systolic BP >120 and <160 mmHg or a diastolic BP >80 and <95 mmHg were considered eligible.
The dietary intervention phase of the trial was designed in two successive dietary periods, each of 5 weeks. Subjects were randomly assigned to the reduced-salt diet or their usual-salt diet (control) for 5 weeks, followed by crossover to the alternative dietary regimen for a further 5 weeks. At baseline (week 0), the subjects visited the Human Nutrition Studies Unit within University College Cork in a fasting state and had their BP measured. Prior to the baseline visit, subjects received instructions on how to collect a 24-h urine sample and were provided with a suitable container for collection. On the day of the baseline visit, subjects brought the 24-h urine sample collected from the previous day and deposited it in a cold room area dedicated for such collections. A blood sample was taken from each subject between 08.30 am and 10.30 am by a trained phlebotomist and anthropometric measures including height and weight, were taken. A health and lifestyle questionnaire, which assessed physical activity, general health, smoking status and alcohol consumption was completed by each subject. Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt, if desired (optional). Subjects commencing the trial on the control diet were allowed to follow their usual diet but were asked to consume an in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g).
During the intervention phase, each participant made 2 further visits to the study unit, one each on the last day of dietary period 1 (week 5) and dietary period 2 (week 10). At these visits, BP measurements were taken as well as other anthropometric measures, including height and weight. An overnight fasting blood sample was also taken from each participant between 08.30 am and 10.30 am by a trained phlebotomist, and on each of the visits, the subjects provided a 24-hour urine sample collected the previous day. Following blood sampling the participants received their breakfast.
Participants met the research staff weekly to receive breads and no-salt margarine/butter as well as luncheon meats (where applicable), and at these meetings the staff promoted compliance with the intervention and encouraged completion of the study protocol.
- Conditions
- Elevated Blood Pressure
- Being tested
- Usual-salt diet, Reduced-salt diet
- Keywords
- Low-salt bread, Dietary sodium restriction, Pre-hypertension, Hypertension stage 1
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual-salt dietOther
Subjects followed their usual-salt diet but were asked to consume an equivalent in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g).
Reduced-salt dietOther
Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food (salted and naturally salty) and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt if desired (optional).
| Study group | Role | What they receive |
|---|---|---|
| Usual-salt diet | Placebo comparator | Usual-salt diet followed for 5 weeks Receives: Other: Usual-salt diet |
| Reduced-salt diet | Active comparator | Reduced-salt diet followed for 5 weeks Receives: Other: Reduced-salt diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure at end of intervention periods
Measured as seated office systolic blood pressure at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Secondary outcomes (11)
Diastolic blood pressure
Measured as seated office diastolic blood pressure at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Urinary Calcium
Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Urinary N-telopeptides of Type I collagen
Biomarker of bone resorption; Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Serum Parathyroid Hormone
Index of calcium metabolism; Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Serum C-telopeptide of Type I collagen
Biomarker of bone resorption; Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Serum Osteocalcin
Biomarker of bone formation; Assessed in fasting serum collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Serum Bone-specific alkaline phosphatase
Biomarker of bone formation; Assessed in fasting serum collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Plasma triglycerides
Index of circulating lipids and CHD risk; Assessed in fasting plasma collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Serum total-cholesterol
Index of circulating lipids and CHD risk; Assessed in fasting plasma collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Plasma LDL-cholesterol,
Index of circulating lipids and CHD risk; Assessed in fasting plasma collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Plasma HDL-cholesterol
Index of circulating lipids and CHD risk; Assessed in fasting plasma collected at end of usual salt dietary period and at end of reduced-salt dietary period
Measured: After 5 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start3 Jan 2008
- Primary completion30 Jul 2010
- Study completion30 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin D. Cashman, University College Cork
- Investigators
- Kevin D Cashman, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003597
- Sponsor's protocol ID
- 06/rd/c/455
- Acronym
- Saltbreads
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 1 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 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Low-salt' Bread as Part of a Pragmatic Reduced-salt Diet for Lowering Blood Pressure in Adults With Elevated Blood Pressure
- ClinicalTrials.gov ID
- NCT04003597
- Acronym / sponsor ID
- Saltbreads / 06/rd/c/455
- Conditions
- Elevated Blood Pressure
- Keywords
- Low-salt bread, Dietary sodium restriction, Pre-hypertension, Hypertension stage 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 3 Jan 2008 (actual)
- Primary completion
- 30 Jul 2010 (actual)
- Study completion
- 30 Jul 2010 (actual)
- First posted
- 1 Jul 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.
In the context of public health, reformulation of bread in terms of salt content remains an important measure to help achieve a reduction in salt intake in the population. Therefore, the aim of this study was to examine, using a 5-week cross-over design, food-based intervention trial, the potential for inclusion of 'low-salt' bread as part of a pragmatic reduced-salt diet on blood pressure (BP) in adults with slightly to moderately elevated BP.
The study consisted of a randomized crossover trial of the effect of reduced-salt intake or usual-salt intake for 5 weeks on BP (as the primary outcome) in adults with slightly to moderately elevated BP (seated office systolic BP >120 and <160 mmHg or a diastolic BP >80 and <95 mmHg; identified by a pre-screening phase).
Subjects were randomly assigned to the reduced-salt diet or their usual-salt diet (control) for 5 weeks, followed by crossover to the alternative dietary regimen for a further 5 weeks. Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt, if desired (optional); these were supplied regularly by the research staff. Subjects commencing the trial on the control diet were allowed to follow their usual diet but were asked to consume an in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g).
Participants met the research staff weekly to receive breads and no-salt margarine/butter as well as luncheon meats (where applicable), and at these meetings the staff promoted compliance with the intervention and encouraged completion of the study protocol.
BP and other assessments were made at baseline and at the end of week 5 and week 10.
Detailed description
Brief background and context for the study:
The World Health Organization's Global Action Plan for the Prevention and Control of Non-Communicable Disease includes a voluntary global target of a 30% relative reduction in mean population intake of salt/sodium by 2025. Bread and cured/processed meats collectively contribute anything from about a third upwards of total salt intake of adults in many Western countries. Reformulation of bread in terms of salt content remains an important measure to help achieve a reduction in salt intake in the population. Therefore, the aim of this study was to examine, using a 5-week cross-over design, food-based intervention trial, the potential for inclusion of 'low-salt' bread as part of a pragmatic reduced-salt diet on blood pressure (BP) in adults with slightly to moderately elevated BP.
Design:
The study consisted of a randomized crossover trial of the effect of reduced-salt intake or usual-salt intake for 5 weeks on BP (primary outcome) and biochemical markers of calcium and bone metabolism as well as plasma lipids (secondary outcomes) in adults with slightly to moderately elevated BP.
Potential volunteers were screened for BP over 3 weeks preceding the intervention phase of the trial during which seated office systolic and diastolic BP were measured weekly and those with systolic BP >120 and <160 mmHg or a diastolic BP >80 and <95 mmHg were considered eligible.
The dietary intervention phase of the trial was designed in two successive dietary periods, each of 5 weeks. Subjects were randomly assigned to the reduced-salt diet or their usual-salt diet (control) for 5 weeks, followed by crossover to the alternative dietary regimen for a further 5 weeks. At baseline (week 0), the subjects visited the Human Nutrition Studies Unit within University College Cork in a fasting state and had their BP measured. Prior to the baseline visit, subjects received instructions on how to collect a 24-h urine sample and were provided with a suitable container for collection. On the day of the baseline visit, subjects brought the 24-h urine sample collected from the previous day and deposited it in a cold room area dedicated for such collections. A blood sample was taken from each subject between 08.30 am and 10.30 am by a trained phlebotomist and anthropometric measures including height and weight, were taken. A health and lifestyle questionnaire, which assessed physical activity, general health, smoking status and alcohol consumption was completed by each subject. Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt, if desired (optional). Subjects commencing the trial on the control diet were allowed to follow their usual diet but were asked to consume an in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g).
During the intervention phase, each participant made 2 further visits to the study unit, one each on the last day of dietary period 1 (week 5) and dietary period 2 (week 10). At these visits, BP measurements were taken as well as other anthropometric measures, including height and weight. An overnight fasting blood sample was also taken from each participant between 08.30 am and 10.30 am by a trained phlebotomist, and on each of the visits, the subjects provided a 24-hour urine sample collected the previous day. Following blood sampling the participants received their breakfast.
Participants met the research staff weekly to receive breads and no-salt margarine/butter as well as luncheon meats (where applicable), and at these meetings the staff promoted compliance with the intervention and encouraged completion of the study protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual-salt diet | Placebo comparator | Other: Usual-salt dietUsual-salt diet followed for 5 weeks |
| Reduced-salt diet | Active comparator | Other: Reduced-salt dietReduced-salt diet followed for 5 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- consenting adult Caucasian men and women, aged ≤65 y;
- a seated office systolic BP >120 and <160 mmHg and/or a diastolic BP >80 and <95 mmHg (based on the mean BP across 3 screening visits as part of a pre-intervention phase of the trial)
- willing to consume study breads
Key exclusion criteria (8 listed)
- taking anti-hypertensive medication;
- taking any medications known to interfere with blood pressure or calcium or bone metabolism;
- Severe medical illness;
- celiac disease;
- hypercalcemia;
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 |
|---|---|---|
| Usual-salt dietSubjects followed their usual-salt diet but were asked to consume an equivalent in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g). | Other | Usual-salt diet |
| Reduced-salt dietSubjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food (salted and naturally salty) and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt if desired (optional). | Other | Reduced-salt diet |
Primary outcome
Systolic blood pressure at end of intervention periods
Time frame: After 5 weeks of intervention
Measured as seated office systolic blood pressure at end of usual salt dietary period and at end of reduced-salt dietary period
11 secondary outcomes
Diastolic blood pressure
Time frame: After 5 weeks of intervention
Urinary Calcium
Time frame: After 5 weeks of intervention
Urinary N-telopeptides of Type I collagen
Time frame: After 5 weeks of intervention
Serum Parathyroid Hormone
Time frame: After 5 weeks of intervention
Serum C-telopeptide of Type I collagen
Time frame: After 5 weeks of intervention
Serum Osteocalcin
Time frame: After 5 weeks of intervention
Serum Bone-specific alkaline phosphatase
Time frame: After 5 weeks of intervention
Plasma triglycerides
Time frame: After 5 weeks of intervention
Serum total-cholesterol
Time frame: After 5 weeks of intervention
Plasma LDL-cholesterol,
Time frame: After 5 weeks of intervention
Plasma HDL-cholesterol
Time frame: After 5 weeks of intervention
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 1 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.
Kevin D Cashman, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual-salt diet and Reduced-salt diet in people with Elevated Blood Pressure, run by University College Cork at 1 site in Ireland.
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 3 inclusion and 8 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 1 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 Ireland. 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?
Systolic blood pressure at end of intervention periods (time frame: After 5 weeks of intervention). 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 1 Jul 2019.