Recruiting
Early Phase 1

Observational Study

Sponsor:

Augusta University

Code:

NCT04958148

Conditions

High Blood Pressure

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Salt pills

Placebo pills

Study Details

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

Study ID

NCT04958148

Start date

Dec 18, 2020

Status verified date

Jun, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: High sodium

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.

placebo comparator: Placebo

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

Interventions

Salt pills

Subjects will supplement salt pills with meals.

Placebo pills

Subjects will supplement placebo pills with meals.

Primary outcome measure

  • Gut microbiota diversity using 16s rRNA Sequencing [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Haidong Zhu, MD, PhD

706-721-4534hzhu@augusta.edu

Yanbin Dong, MD, PhD

706-721-4534ydong@augusta.edu

Locations

Georgia Prevention Institute/ Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Haidong Zhu, MD, PhD

706-712-4534hzhu@augusta.edu

Yanbin Dong, MD, PhD

706-721-4534ydong@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jul 12, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2021-07-12.