Trial Outcomes & Findings for Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults (NCT NCT01566084)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)

Results posted on

2016-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Slow Sodium Tablets (Start) 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 opposite condition in the second half of the study.	Placebo 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 opposite condition in the second half of the study.
Overall Study STARTED	7	10
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Slow Sodium Tablets (Start) n=7 Participants Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day. Subjects then cross-over to the placebo arm in the second half of the study.	Placebo (Start) n=10 Participants 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 slow sodium tablet arm in the second half of the study.	Total n=17 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 7 • n=5 Participants	62 years STANDARD_DEVIATION 7 • n=7 Participants	62 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)

Population: All subjects are analyzed under each condition because of the cross-over design.

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.

Outcome measures

Outcome measures
Measure	Normal Sodium Diet n=17 Participants Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.	Low Sodium Diet. n=17 Participants Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.	Normal Sodium Ascorbic Acid 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. FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline.	Low Sodium Ascorbic Acid 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. FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline.
Improved Flow Mediated Dilation	3.57 percentage dilation Standard Deviation 1.59	6.01 percentage dilation Standard Deviation 2.31	—	—

SECONDARY outcome

Timeframe: Immediately following acute infusion of ascorbic acid on Weeks 5 and 10

Population: Ascorbic acid is missing in one participant due to a failed i.v.

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.

Outcome measures

Outcome measures
Measure	Normal Sodium Diet n=17 Participants Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.	Low Sodium Diet. n=17 Participants Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.	Normal Sodium Ascorbic Acid n=16 Participants 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. FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline.	Low Sodium Ascorbic Acid n=16 Participants 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. FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline.
Vascular Oxidative Stress	3.57 percentage dilation Standard Deviation 1.69	6.01 percentage dilation Standard Deviation 2.31	4.90 percentage dilation Standard Deviation 2.84	5.51 percentage dilation Standard Deviation 2.36

SECONDARY outcome

Timeframe: Immediately following acute administration of BH4 on Weeks 5 and 10

Population: BH4 could not be administered to 3 participants due to canceled visits.

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.

Outcome measures

Outcome measures
Measure	Normal Sodium Diet n=17 Participants Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.	Low Sodium Diet. n=17 Participants Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.	Normal Sodium Ascorbic Acid n=14 Participants 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. FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline.	Low Sodium Ascorbic Acid n=14 Participants 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. FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline.
BH4 Bioavailability	3.57 percentage dilation Standard Deviation 1.69	6.01 percentage dilation Standard Deviation 2.31	5.78 percentage dilation Standard Deviation 2.02	6.11 percentage dilation Standard Deviation 2.32

Adverse Events

Normal Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kristen Jablonski

University of Colorado Denver

Phone: 303-724-4842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place