The primary objective is to determine the effect of (1) increased sodium intake and (2) increased potassium intake on flow-mediated dilation (FMD) and systolic blood pressure (SBP) in untreated (pre)hypertensive subjects
ID
Source
Brief title
Condition
- Other condition
- Vascular hypertensive disorders
Synonym
Health condition
nierfunctie (estimated glomerular filtration rate)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters is flow-mediated dilation (FMD).
Secondary outcome
Secondary parameters involve: diastolic blood pressure (DBP), centrale blood
pressure, 24-hour ambulatory blood pressure, augmentation index (Aix), pulse
wave velocity (PWV), vasomotion, estimated glomerular filtration rate (eGFR)
and plasma biomarkers of endothelial function and low-grade inflammation, as
asymmetric dimethylarginine (ADMA), endothelin-1, nitric oxides (NOx), monocyte
chemoattractant protein (MCP-1), soluble endothelin selection (sE-selectin),
soluble-thrombomodulin (sTM), von Willebrand factor (vWF), the cell adhesion
molecules sVCAM-1 and sICAM-1, C-reactive protein (CRP), serum amyloid A (SAA),
interleukin 6 (IL-6), interleukin 8 (IL-8) and tumor necrosis factor-α (TNF-α)
Background summary
Identifying factors that influence vascular function and blood pressure has
important implications for preventing CVD, which is the leading cause of death
in modern societies. A large body of evidence supports the view of associations
between sodium and potassium intake and blood pressure, but the effects of
these minerals on vascular function and renal function are less conclusive.
Study objective
The primary objective is to determine the effect of (1) increased sodium intake
and (2) increased potassium intake on flow-mediated dilation (FMD) and systolic
blood pressure (SBP) in untreated (pre)hypertensive subjects
Study design
Randomized, double-blind, placebo controlled cross-over feeding study .
Intervention
One-week run-in period, followed by 3 periods of 4 weeks intervention. During
the run-in period and intervention periods the subjects will remain on a
low-sodium, low-potassium diet, which provides 2 grams of sodium (5 grams NaCl)
and 2 grams of potassium on a daily basis. After the run-in, the subjects will
receive in random order for periods of 4 weeks:
1. Sodium chloride supplements (increased sodium intake of 3 g/d = 7.5 g/d
NaCl),
2. Potassium chloride supplements (increased potassium intake of 3 g/d) or
3. Placebo (cellulose) supplements (*low sodium, low potassium phase*).
Study burden and risks
The reached sodium and potassium intake during the different interventions
falls within the range that Dutch persons consume. Next to that, only persons
that are apparently healthy (besides their elevated blood pressure) can
participate. Important is that they have a good renal function and therefore
the renal function will be determined during screening. It is likely that the
blood pressure will increase during the period with increased sodium intake and
decrease in the period with increased potassium intake. These changes will be
temporary. If SBP becomes 160 mm Hg or above, the subject and the general
practitioner will be informed. There is no direct (health-related) benefit for
the participant. A burden for the subjects may be the restricted diet, the
consumption of the diet at the Division of Human Nutrition, the consumption of
capsules and the measurements during the test days.
Nieuwe Kanaal 9A
6709 PA Wageningen
NL
Nieuwe Kanaal 9A
6709 PA Wageningen
NL
Listed location countries
Age
Inclusion criteria
Systolic Blood Pressure between 130-159
No use of cardiovascular medication
Age 40 years and over
Exclusion criteria
Chronic diseases (as diabetes, cardiovascular diseases, renal impairment)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38415.081.11 |