Salt and Gut Study

High Blood Pressure Clinical Trial

Official title:

High Sodium Intake, Gut Microbiome and Blood Pressure Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958148
• Other study ID #: 1612471
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 18, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Augusta University
• Contact: Haidong Zhu, MD, PhD
• Phone: 706-721-4534
• Email: hzhu[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Dietary Supplement:
• Salt pills
Subjects will supplement salt pills with meals.
• Placebo pills
Subjects will supplement placebo pills with meals.

Locations

Country	Name	City	State
United States	Georgia Prevention Institute/ Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks