Salt and Gut Study

NCT04958148 | Unknown Early Phase 1

• 1 other identifier: 1612471
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gut intestine barrier integrity measured by non-invasive biomarkers

  4 weeks

Study Arms (2)

High sodium

EXPERIMENTAL

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.

Dietary Supplement: Salt pills

Placebo

PLACEBO COMPARATOR

Subjects will be counseled to consume a diet with 2,300 mg/d sodium and will supplement with taking placebo pills for 4 weeks.

Dietary Supplement: Placebo pills

Interventions

Salt pills DIETARY_SUPPLEMENT

Subjects will supplement salt pills with meals.

High sodium

Placebo pills DIETARY_SUPPLEMENT

Subjects will supplement placebo pills with meals.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Georgia Prevention Institute/ Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Haidong Zhu, MD, PhD

CONTACT

706-721-4534; hzhu@augusta.edu

Yanbin Dong, MD, PhD

CONTACT

706-721-4534; ydong@augusta.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: July 12, 2021
• Study Start: December 18, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 12, 2021

Record last verified: 2021-06

Locations

US (1)