NCT04994418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

April 16, 2021

Last Update Submit

December 4, 2024

Conditions

Blood PressureInflammation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Arm 1. Recommended sodium and low fructose diet

EXPERIMENTAL

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 dietDietary Supplement: High sodium and high fructose diet

Arm 2. High sodium and low fructose diet

EXPERIMENTAL

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 dietDietary Supplement: High sodium and high fructose diet

Arm 3. High sodium and high fructose diet

EXPERIMENTAL

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 dietDietary Supplement: High sodium and low fructose diet

Interventions

Recommended sodium and low fructose dietDIETARY_SUPPLEMENT

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.

Arm 2. High sodium and low fructose dietArm 3. High sodium and high fructose diet
High sodium and low fructose dietDIETARY_SUPPLEMENT

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.

Arm 1. Recommended sodium and low fructose dietArm 3. High sodium and high fructose diet
High sodium and high fructose dietDIETARY_SUPPLEMENT

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.

Arm 1. Recommended sodium and low fructose dietArm 2. High sodium and low fructose diet

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal blood pressure
  • males, females, minorities

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald K McMillan, M.S

    University of Delaware

    PRINCIPAL INVESTIGATOR

  • William B Farquhar, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

August 6, 2021

Study Start

April 1, 2021

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

US(1)