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NCT Number: NCT01628302

Effect of Salt Restriction on Renin Activation

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lowering salt in diet

Behavioral

Low salt diet (50mmol)for three weeks.

Primary outcomes

  1. 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

  1. Change in sodium levels in urine samples.

    Time frame: 3 weeks

    Sodium was measured in 24-hour collected urine samples 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.

  2. Change in plasma renin activity

    Time frame: For 3 times in 8 weeks

    Plasma renin activity level was measured in the blood samples collected, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.

  3. Change in aldosterone level in blood samples

    Time frame: For 3 times in 8 weeks

    Aldosterone levels was measured in the blood samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.

  4. Change in potassium levels in urine samples.

    Time frame: 3 weeks

    Potassium was measured in 24-hour collected urine samples 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.

  5. Change in urea level in urine samples

    Time frame: 3 weeks

    Urea was measured in 24-hour collected urine samples 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

  6. Change in creatinin level in urine samples

    Time frame: 3 weeks

    Creatinin was measured in 24-hour collected urine samples 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.

  7. Change in microalbumin level in urine samples

    Time frame: 3 weeks

    Microalbumin was measured in 24-hour collected urine samples 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

  8. Change in aldosterone level in urine samples

    Time frame: For 3 times in 8 weeks

    Aldosterone levels was measured in in the 24-hour urine samples collected , at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet.

Sponsors and collaborators

Lead sponsor

Turkish Society of Hypertension and Renal Diseases

Other

Registry information

Official study title

Investigation of Salt Restriction Effect on Renin Activation

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 26, 2012
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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