Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults
|ClinicalTrials.gov Identifier: NCT01566084|
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : June 20, 2014
Last Update Posted : January 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Slow sodium tablets Other: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake. Subjects then cross-over to the low sodium condition in the second half of the study.
Drug: Slow sodium tablets
The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets.
Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet. Subjects then cross-over to the normal sodium condition in the second half of the study.
Placebo tablets are administered to maintain the low sodium condition.
- Improved Flow Mediated Dilation [ Time Frame: Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first) ]FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.
- Vascular Oxidative Stress [ Time Frame: Immediately following acute infusion of ascorbic acid on Weeks 5 and 10 ]Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.
- BH4 Bioavailability [ Time Frame: Immediately following acute administration of BH4 on Weeks 5 and 10 ]Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566084
|United States, Colorado|
|Clinical Translational Research Center|
|Boulder, Colorado, United States, 80309|
|Principal Investigator:||Kristen L Jablonski, PhD||University of Colorado, Boulder|