Salt and Gut Study
Primary Purpose
High Blood Pressure
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Salt pills
Placebo pills
Sponsored by

About this trial
This is an interventional prevention trial for High Blood Pressure
Eligibility Criteria
Inclusion criteria:
- Aged between 18-50 years
- African Americans (AAs) or European Americans (EAs)
- BP <140/90 mmHg
- Not on any prescription medications
- Normal kidney function (eGFR ≥ 90 ml/min/1.73 m2)
Exclusion criteria:
- Pregnant or nursing
- Previous diagnosis of major cardiovascular diseases including myocardial infarction, congestive heart failure or stroke, diabetes, autoimmune, chronic liver and kidney disease
- Previous diagnosis of Crohn's disease or any other intestinal conditions
- Previous diagnosis of major lung diseases such as chronic obstructive pulmonary disease (COPD)
- Previous diagnosis of cancer
- Alcohol and drug abuse.
Sites / Locations
- Georgia Prevention Institute/ Augusta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
High sodium
Placebo
Arm Description
Subjects will be counseled to consume a diet with 2,300 mg/d sodium which they will supplement with pills containing salt to achieve an intake of 4,300 mg/d sodium for 4 weeks.
Subjects will be counseled to consume a diet with 2,300 mg/d sodium and will supplement with taking placebo pills for 4 weeks.
Outcomes
Primary Outcome Measures
Gut microbiota diversity using 16s rRNA Sequencing
Subjects will be provided instructions and kits on how to collect feces and saliva samples. Saliva samples will be collected on the testing day. Feces sample will be collected on the testing day if possible; if not, it will be brought back the following day. DNA will be extracted from collected feces and saliva samples using the MoBioPowerSoil kit. The V3-V5 region of the 16S rRNA will be amplified and sequenced using the Illumina MiSeq platform. The outcome variables for microbiome data will be alpha diversity, beta diversity, and overall composition.
Secondary Outcome Measures
Gut intestine barrier integrity measured by non-invasive biomarkers
Gut intestine barrier function will be determined by non-invasive biomarkers. Plasma LPS, I-FABP, DAO, zonulin, IL-6, TLR4 will be measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04958148
Brief Title
Salt and Gut Study
Official Title
High Sodium Intake, Gut Microbiome and Blood Pressure Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University
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
High sodium intake is a significant risk factor for hypertension. Recently, animal studies connect high sodium intake to the gut-immune axis and highlight the gut microbiome as a potential therapeutic target to counteract salt-sensitive conditions and hypertension. The objective of this project is to determine the effects of high salt intake on gut microbiota composition and gut intestine barrier integrity, leading to increased BP in humans. The investigators also hypothesize that high salt intake affects the gut microbiome in a sex-specific manner. In this pilot study, The investigators also test whether telehealth or in-person nutritional coaching help to decrease dietary sodium intake and improve diet quality
Detailed Description
The investigators will conduct a randomized, double-blind, placebo-controlled trial in normotensive and stage 1 hypertensive drug naïve participants (age 18-50 years, equal distribution of blacks and whites, and males and females, BP <140/90 mmHg). The average intake of sodium in the American diet is 3,400 mg per day. The average recommended dose is 2,300 mg per day. Eligible participants will be enrolled and provided with one-hour in-person/telehealth nutritional counseling at the GPI to reduce their sodium intake by 1,100 mg per day to achieve the sodium intake of 2,300 mg/day. Participants will then be randomized to receive either placebo or salt pills of 2,000 mg per day for four weeks while continuously receiving weekly telehealth nutritional counseling. The salt group's sodium intake will be 4,300 mg per day, while the sodium intake in the placebo group will be 2,300 mg per day. Participants will have a follow-up visit at six months after the 4-week sodium intervention. Participants will be tested four times (Figure 1). Participants will receive the first 1-hour in-person/telehealth nutrition counseling at GPI (baseline) and three weekly telehealth nutrition counseling during the 4-week intervention period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, double-blind, placebo-controlled trial. Half the participants will be in placebo arm, the other half will be in salt arm.
Masking
ParticipantInvestigator
Masking Description
Double blind
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High sodium
Arm Type
Experimental
Arm Description
Subjects will be counseled to consume a diet with 2,300 mg/d sodium which they will supplement with pills containing salt to achieve an intake of 4,300 mg/d sodium for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be counseled to consume a diet with 2,300 mg/d sodium and will supplement with taking placebo pills for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Salt pills
Intervention Description
Subjects will supplement salt pills with meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo pills
Intervention Description
Subjects will supplement placebo pills with meals.
Primary Outcome Measure Information:
Title
Gut microbiota diversity using 16s rRNA Sequencing
Description
Subjects will be provided instructions and kits on how to collect feces and saliva samples. Saliva samples will be collected on the testing day. Feces sample will be collected on the testing day if possible; if not, it will be brought back the following day. DNA will be extracted from collected feces and saliva samples using the MoBioPowerSoil kit. The V3-V5 region of the 16S rRNA will be amplified and sequenced using the Illumina MiSeq platform. The outcome variables for microbiome data will be alpha diversity, beta diversity, and overall composition.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Gut intestine barrier integrity measured by non-invasive biomarkers
Description
Gut intestine barrier function will be determined by non-invasive biomarkers. Plasma LPS, I-FABP, DAO, zonulin, IL-6, TLR4 will be measured.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Aged between 18-50 years
African Americans (AAs) or European Americans (EAs)
BP <140/90 mmHg
Not on any prescription medications
Normal kidney function (eGFR ≥ 90 ml/min/1.73 m2)
Exclusion criteria:
Pregnant or nursing
Previous diagnosis of major cardiovascular diseases including myocardial infarction, congestive heart failure or stroke, diabetes, autoimmune, chronic liver and kidney disease
Previous diagnosis of Crohn's disease or any other intestinal conditions
Previous diagnosis of major lung diseases such as chronic obstructive pulmonary disease (COPD)
Previous diagnosis of cancer
Alcohol and drug abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haidong Zhu, MD, PhD
Phone
706-721-4534
Email
hzhu@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yanbin Dong, MD, PhD
Phone
706-721-4534
Email
ydong@augusta.edu
Facility Information:
Facility Name
Georgia Prevention Institute/ Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidong Zhu, MD, PhD
Phone
706-712-4534
Email
hzhu@augusta.edu
First Name & Middle Initial & Last Name & Degree
Yanbin Dong, MD, PhD
Phone
706-721-4534
Email
ydong@augusta.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If we can share data without risking the identity of our participants, we will plan to share.
Learn more about this trial
Salt and Gut Study
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