Salt and Gut Study

NCT ID: NCT04958148

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2022-12-31

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.

Conditions

High Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Salt pills

Intervention Type: DIETARY_SUPPLEMENT

Subjects will supplement salt pills with meals.

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.

Group Type: PLACEBO_COMPARATOR

Placebo pills

Intervention Type: DIETARY_SUPPLEMENT

Subjects will supplement placebo pills with meals.

Interventions

Salt pills

Subjects will supplement salt pills with meals.

Intervention Type: DIETARY_SUPPLEMENT

Placebo pills

Subjects will supplement placebo pills with meals.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Georgia Prevention Institute/ Augusta University

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Haidong Zhu, MD, PhD

Role: CONTACT

hzhu@augusta.edu

706-721-4534

Yanbin Dong, MD, PhD

Role: CONTACT

ydong@augusta.edu

706-721-4534

Facility Contacts

Haidong Zhu, MD, PhD

Role: primary

hzhu@augusta.edu

706-712-4534

Yanbin Dong, MD, PhD

Role: backup

ydong@augusta.edu

706-721-4534

Other Identifiers

1612471

Identifier Type: -

Identifier Source: org_study_id