Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Aga Khan University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
Study Overview
Brief Summary
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure relationship remains controversial.
While clinical practice guidelines recommend dietary salt restriction for lowering blood pressure, the relationship of salt with blood pressure has not been tested in the Pakistani population. Therefore, the efficacy of dietary salt restriction on blood pressure of this population remains to be determined. The study aims to determine the relationship between dietary salt intake and blood pressure in Pakistani population. It is hypothesized that alteration in the dietary salt intake demonstrates significant changes in the Systolic BP.
Detailed Description
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure relationship remains controversial.
While clinical practice guidelines recommend dietary salt restriction for lowering blood pressure, the relationship of salt with blood pressure has not been tested in the Pakistani population. Therefore, the efficacy of dietary salt restriction on blood pressure of this population remains to be determined.
Objectives:
- To assess the effects of low salt diet versus high salt diet on blood pressure in normotensive adults aged 40 years or above in Karachi, Pakistan
- To estimate the prevalence of salt sensitivity and salt resistance in normotensive adults aged 40 years or above in Karachi, Pakistan
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects aged 40 years and above
- •With systolic BP <140 and diastolic < 90 mmHg
- •Not receiving pharmacological antihypertensive medications
Exclusion Criteria
- •Subjects with following conditions would be excluded:
- •Diabetes mellitus (positive history of diabetes or fasting blood sugar ≥ 126 mg/dl)
- •Renal insufficiency (serum creatinine of 1.4 mg/dl or above)
- •Pregnant or lactating women
Outcomes
Primary Outcomes
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
Secondary Outcomes
- Salt Sensitivity defined as an increase in SBP of at least 8 mmHg at the end of high salt phase compared with the end of low salt phase.
- Salt Resistance would be defined as those with rise of < 4 mm Hg of SBP at the end of high salt phase compared with the end of low salt phase.