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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Ireland

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.

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 groups in NCT04003597
Study groupRoleWhat they receive
Usual-salt dietPlacebo comparatorUsual-salt diet followed for 5 weeks
Receives: Other: Usual-salt diet
Reduced-salt dietActive comparatorReduced-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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted1 Jul 2019
  2. Study start3 Jan 2008
  3. Primary completion30 Jul 2010
  4. Study completion30 Jul 2010

Resources

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)
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

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.

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