The Impact of Sodium and Fructose on Blood Pressure and Inflammation

The goal of this study is to determine the impact of dietary sodium and fructose on blood pressure and inflammation in young healthy adults.

Study Overview

• Status: Completed
• Conditions: Inflammation; Blood Pressure
• Intervention / Treatment: Dietary supplement: High sodium and low fructose diet; Dietary supplement: High sodium and high fructose diet; Dietary supplement: Recommended sodium and low fructose diet

Detailed Description

Excess dietary salt is associated with an increased risk of cardiovascular diseases. Some healthy adults have been determined to be more sensitive to dietary salt than others, which can result in a 10% or more increase of blood pressure. The mechanisms underlying salt sensitivity of blood pressure are not fully understood. Previous research has suggested excess intake of added sugars, especially fructose, can increase salt sensitivity of blood pressure. Chronic elevated consumption of salt and fructose independently have been shown to have damaging effects on the body, however, the combination of both salt and fructose has not been fully studied in humans. The purpose of this research study is to determine if increased dietary fructose consumption will stimulate salt-sensitive hypertension and induce proinflammatory cytokines through activation of the immune system. Understanding how the body regulates blood pressure during times of elevated salt and fructose is important for determining cardiovascular risk in a population with normal blood pressure.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• normal blood pressure
• males, females, minorities

Exclusion Criteria:

• high blood pressure
• body mass index (BMI) of > 30 kg/m2
• smokers or nicotine users
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1. Recommended sodium and low fructose diet; 7 day consumption of low fructose drink (20g) and recommended sodium (2300mg) from whole food while consuming placebo from pills	Dietary supplement: High sodium and low fructose diet; Upon completion of a 7 day dietary intervention of consuming the daily high sodium and low fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.; Dietary supplement: High sodium and high fructose diet; Upon completion of a 7 day dietary intervention of consuming the high sodium and high fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.
Experimental: Arm 2. High sodium and low fructose diet; 7 day consumption of low fructose drink (20g) and recommended sodium (2300 mg) from whole food while consuming high sodium from pills (3400 mg)	Dietary supplement: High sodium and high fructose diet; Upon completion of a 7 day dietary intervention of consuming the high sodium and high fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.; Dietary supplement: Recommended sodium and low fructose diet; Upon completion of a 7 day dietary intervention of consuming the daily recommended sodium and low fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.
Experimental: Arm 3. High sodium and high fructose diet; 7 day consumption of high fructose drink (200g) and recommended sodium (2300 mg)from whole food while consuming high sodium pills from pills (3400 mg)	Dietary supplement: High sodium and low fructose diet; Upon completion of a 7 day dietary intervention of consuming the daily high sodium and low fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.; Dietary supplement: Recommended sodium and low fructose diet; Upon completion of a 7 day dietary intervention of consuming the daily recommended sodium and low fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour Blood Pressure	Systolic blood pressure over 24 hours (mmHg)	Day 7 of diet intervention
Inflammatory cytokines	ELISA assay detecting Interleukin-6 and tumor necrosis factor-alpha	Day 7 of diet intervention

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: William B Farquhar, PhD, University of Delaware; Principal Investigator: Ronald K McMillan, M.S, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 1617405-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No