The Impact of Sodium and Fructose on Blood Pressure and Inflammation

Inflammation Clinical Trial

Official title:

The Impact of Sodium and Fructose on Blood Pressure and Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994418
• Other study ID #: 1617405-2
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: December 2023
• Source: University of Delaware
• Contact: Ronald K McMillan, M.S
• Phone: 302-544-0030
• Email: rmcmill[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Inflammation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

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