Investigation of Salt Restriction Effect on Renin Activation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Primary Endpoint
- Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
Study Overview
Brief Summary
The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects.
Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects.
Detailed Description
The present study is carried out with the subjects who are chosen among the nursing home residents in İzmir. The subjects were randomized to 2 groups and while one of these groups had low salt diet (50mmol), the other group had normal salt diet (250mmol) for 3 weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks. According to crossover nature of the study, the group that had normal salt diet at the first 3 weeks of study had low salt diet at the last 3 weeks of the study. The other group that had low salt diet had the normal salt diet at the last 3 week of the study.
At the beginning of the study, information such as demographic, family story, medical story, diet habits, concomitant medication and physical measurements (height, weight and waist circumference) were received from the subjects.
24 hour blood pressure of the subjects is measured for four times, before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. The subjects were asked for collecting 24-h urine in the same days of blood pressure measurement. Sodium, potassium, urea, creatinin and microalbumin measurements were measured in the collected urine. Blood samples were collected for three times, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. Plasma renin activity and aldosterone levels were measured in the blood samples collected. Aldosterone level was measured in the 24-hour urine in mentioned days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who are 50 years and older
- •Subjects whose systolic blood pressure is ≥ 140 mmHg
- •Subjects whose diastolic blood pressure is ≥ 90 mmHg
- •Subjects who is normal weighted defined as body mass index < 25 or who is obese defined as body mass index > 30
- •Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
- •Informed about the study and consented to include the study
Exclusion Criteria
- •Known heart failure
- •Known renal failure
- •Known chronic liver disease
- •Antihypertensive drug use
- •nonsteroidal anti inflammatory (NSAI) drug use
Outcomes
Primary Outcomes
Change from baseline in 24-hour ambulatory blood pressure at 3 weeks
Time Frame: 3 weeks
24-hour ambulatory blood pressure was measured before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.
Secondary Outcomes
- Change in sodium levels in urine samples.(3 weeks)
- Change in plasma renin activity(For 3 times in 8 weeks)
- Change in aldosterone level in blood samples(For 3 times in 8 weeks)
- Change in potassium levels in urine samples.(3 weeks)
- Change in urea level in urine samples(3 weeks)
- Change in creatinin level in urine samples(3 weeks)
- Change in microalbumin level in urine samples(3 weeks)
- Change in aldosterone level in urine samples(For 3 times in 8 weeks)