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'Low-salt' Bread as a Means of Reducing Dietary Salt and Lowering Blood Pressure

'Low-salt' Bread as Part of a Pragmatic Reduced-salt Diet for Lowering Blood Pressure in Adults With Elevated Blood Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04003597
Acronym
Saltbreads
Enrollment
97
Registered
2019-07-01
Start date
2008-01-03
Completion date
2010-07-30
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated Blood Pressure

Keywords

Low-salt bread, Dietary sodium restriction, Pre-hypertension, Hypertension stage 1

Brief 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 '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.

Interventions

OTHERUsual-salt diet

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).

OTHERReduced-salt diet

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).

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The biochemical outcome measures were assessed by researchers masked to the phase of the cross-over intervention from which the samples were derived.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressure at end of intervention periodsAfter 5 weeks of interventionMeasured as seated office systolic blood pressure at end of usual salt dietary period and at end of reduced-salt dietary period

Secondary

MeasureTime frameDescription
Urinary CalciumAfter 5 weeks of interventionAssessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Urinary N-telopeptides of Type I collagenAfter 5 weeks of interventionBiomarker of bone resorption; Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Serum Parathyroid HormoneAfter 5 weeks of interventionIndex of calcium metabolism; Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Serum C-telopeptide of Type I collagenAfter 5 weeks of interventionBiomarker of bone resorption; Assessed in 24-hour urine collected at end of usual salt dietary period and at end of reduced-salt dietary period
Serum OsteocalcinAfter 5 weeks of interventionBiomarker of bone formation; Assessed in fasting serum collected at end of usual salt dietary period and at end of reduced-salt dietary period
Diastolic blood pressureAfter 5 weeks of interventionMeasured as seated office diastolic blood pressure at end of usual salt dietary period and at end of reduced-salt dietary period
Serum total-cholesterolAfter 5 weeks of interventionIndex 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
Plasma triglyceridesAfter 5 weeks of interventionIndex 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
Plasma LDL-cholesterol,After 5 weeks of interventionIndex 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
Plasma HDL-cholesterolAfter 5 weeks of interventionIndex 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
Serum Bone-specific alkaline phosphataseAfter 5 weeks of interventionBiomarker of bone formation; Assessed in fasting serum collected at end of usual salt dietary period and at end of reduced-salt dietary period

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026