The Impact of Sodium and Fructose on Blood Pressure and Inflammation

Not Applicable

Completed

• Conditions: Blood Pressure; Inflammation
• Interventions: Dietary Supplement: High sodium and low fructose diet; Dietary Supplement: Recommended sodium and low fructose diet; Dietary Supplement: High sodium and high fructose diet

• Registration Number: NCT04994418
• Lead Sponsor: University of Delaware

Brief 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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-06
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1. Recommended sodium and low fructose diet	High 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
Arm 3. High sodium and high fructose diet	Recommended sodium and low 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)
Arm 1. Recommended sodium and low fructose diet	High sodium and high fructose diet	7 day consumption of low fructose drink (20g) and recommended sodium (2300mg) from whole food while consuming placebo from pills
Arm 2. High sodium and low fructose diet	Recommended 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)
Arm 2. High sodium and low fructose diet	High sodium and high 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)
Arm 3. High sodium and high fructose diet	High sodium and low 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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States