The Impact of Sodium and Fructose on Blood Pressure and Inflammation

Sponsor
University of Delaware (Other)
Overall Status
Recruiting
CT.gov ID
NCT04994418
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
25
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Recommended sodium and low fructose diet
  • Dietary Supplement: High sodium and low fructose diet
  • Dietary Supplement: High sodium and high fructose diet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Impact of Sodium and Fructose on Blood Pressure and Inflammation
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

ArmIntervention/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: 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.

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 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: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 24-hour Blood Pressure [Day 7 of diet intervention]

    Systolic blood pressure over 24 hours (mmHg)

  2. Inflammatory cytokines [Day 7 of diet intervention]

    ELISA assay detecting Interleukin-6 and tumor necrosis factor-alpha

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of DelawareNewarkDelawareUnited States19713

Sponsors and Collaborators

  • University of Delaware

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
William Farquhar, Professor, University of Delaware
ClinicalTrials.gov Identifier:
NCT04994418
Other Study ID Numbers:
  • 1617405-2
First Posted:
Aug 6, 2021
Last Update Posted:
Aug 6, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 6, 2021