N/A
N=17
Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01566084 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Improved Flow Mediated Dilation — 3.57; 6.01 percentage dilation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Slow sodium tablets (Drug); placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Boulder
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improved Flow Mediated Dilation |
3.57; 6.01 | — |
| SECONDARY Vascular Oxidative Stress |
3.57; 6.01; 4.90; 5.51 | — |
| SECONDARY BH4 Bioavailability |
3.57; 6.01; 5.78; 6.11 | — |
Summary
The investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of BH4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.
Eligibility Criteria
Inclusion Criteria
- 50-79 years of age
- SBP 130-159 mmHg
Exclusion Criteria
- Have been sick with an infection in the past two weeks
- Are currently sick or have ongoing health problems such as kidney or CVD
- Have lost more than 11 lbs. in the last 3 months
- Are taking any type of antioxidants
- Smoke or have alcohol problems
- Have blood glucose levels higher than 126 mg/dL
- Have resting SBP below or less than 100 mmHg or greater than 159 mmHg
- Have a resting diastolic blood pressure greater than 99 mmHg
- Have a BMI greater than 40 kg/m^2
- Are presently consuming less than 9 or greater than 18 grams of salt / day
- Have a baseline FMD of greater than 6%
- Are taking any of the following types of drugs: blood thinners, anti-seizure medications, ant-inflammatory drugs
- Participate in any high endurance athletic training
- Taking Hormone Replacement Therapy
- Have not been post-menopausal for at least 1 year
Data sourced from ClinicalTrials.gov (NCT01566084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.