Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Slow sodium tablets; Other: placebo

Detailed Description

The improvement in blood vessel function will be determined over a 10 week period. Subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. After the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. During weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. The assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. BH4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous BH4 levels and vascular oxidative stress.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Clinical Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Normal sodium; 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.
Other: Low sodium; 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.	Other: placebo; Placebo tablets are administered to maintain the low sodium condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Flow Mediated Dilation	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.	Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular Oxidative Stress	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.	Immediately following acute infusion of ascorbic acid on Weeks 5 and 10
BH4 Bioavailability	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.	Immediately following acute administration of BH4 on Weeks 5 and 10

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kristen L Jablonski, PhD, University of Colorado, Boulder

Publications and helpful links

Helpful Links

• Integrative Physiology of Aging Laboratory Website

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: B5114; F31AG033994 (U.S. NIH Grant/Contract)