The Impact of Sodium and Fructose on Blood Pressure and Inflammation
Primary Purpose
Blood Pressure, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recommended sodium and low fructose diet
High sodium and low fructose diet
High sodium and high fructose diet
Sponsored by
About this trial
This is an interventional basic science trial for Blood Pressure
Eligibility Criteria
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
Sites / Locations
- University of DelawareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1. Recommended sodium and low fructose diet
Arm 2. High sodium and low fructose diet
Arm 3. High sodium and high fructose diet
Arm Description
7 day consumption of low fructose drink (20g) and recommended sodium (2300mg) from whole food while consuming placebo from pills
7 day consumption of low fructose drink (20g) and recommended sodium (2300 mg) from whole food while consuming high sodium from pills (3400 mg)
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)
Outcomes
Primary Outcome Measures
24-hour Blood Pressure
Systolic blood pressure over 24 hours (mmHg)
Inflammatory cytokines
ELISA assay detecting Interleukin-6 and tumor necrosis factor-alpha
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04994418
Brief Title
The Impact of Sodium and Fructose on Blood Pressure and Inflammation
Official Title
The Impact of Sodium and Fructose on Blood Pressure and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1. Recommended sodium and low fructose diet
Arm Type
Experimental
Arm Description
7 day consumption of low fructose drink (20g) and recommended sodium (2300mg) from whole food while consuming placebo from pills
Arm Title
Arm 2. High sodium and low fructose diet
Arm Type
Experimental
Arm Description
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 Title
Arm 3. High sodium and high fructose diet
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Recommended sodium and low fructose diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High sodium and low fructose diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High sodium and high fructose diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
24-hour Blood Pressure
Description
Systolic blood pressure over 24 hours (mmHg)
Time Frame
Day 7 of diet intervention
Title
Inflammatory cytokines
Description
ELISA assay detecting Interleukin-6 and tumor necrosis factor-alpha
Time Frame
Day 7 of diet intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald K McMillan, M.S
Phone
302-544-0030
Email
rmcmill@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
William B Farquhar, PhD
Phone
302-831-6178
Email
wbf@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald K McMillan, M.S
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William B Farquhar, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald K McMillan, M.S
Phone
302-544-0030
Email
rmcmill@udel.edu
First Name & Middle Initial & Last Name & Degree
William B Farquhar, PhD
Phone
302-831-6178
Email
wbf@udel.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Impact of Sodium and Fructose on Blood Pressure and Inflammation
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