High Blood PressureEarly Phase 1NCT04958148
Salt and Gut Study
A Early Phase 1 study testing Salt pills in people with High Blood Pressure, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Salt pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 31 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgia Prevention Institute/ Augusta University
Augusta, Georgia, 30912
Haidong Zhu, MD, PhD, 706-712-4534, hzhu@augusta.edu
Yanbin Dong, MD, PhD, 706-721-4534, ydong@augusta.edu
About this study
Official title: High Sodium Intake, Gut Microbiome and Blood Pressure Control
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
Read the 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
- Being tested
- Salt pills, Placebo pills
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt pillsDietary supplement
Subjects will supplement salt pills with meals.
Placebo pillsDietary supplement
Subjects will supplement placebo pills with meals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start18 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958148
- Sponsor's protocol ID
- 1612471
- Status last verified
- Jun 2021
- First submitted
- 21 May 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If we can share data without risking the identity of our participants, we will plan to share.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sodium Intake, Gut Microbiome and Blood Pressure Control
- ClinicalTrials.gov ID
- NCT04958148
- Acronym / sponsor ID
- 1612471
- Conditions
- High Blood Pressure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High sodium | Experimental | Dietary Supplement: Salt pillsSubjects 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 | Placebo comparator | Dietary Supplement: Placebo pillsSubjects will be counseled to consume a diet with 2,300 mg/d sodium and will supplement with taking placebo pills for 4 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt pillsSubjects will supplement salt pills with meals. | Dietary supplement | High sodium |
| Placebo pillsSubjects will supplement placebo pills with meals. | Dietary supplement | Placebo |
Primary outcome
Gut microbiota diversity using 16s rRNA Sequencing
Time frame: 4 weeks
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.
1 secondary outcome
Gut intestine barrier integrity measured by non-invasive biomarkers
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Undecided. If we can share data without risking the identity of our participants, we will plan to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Salt pills in people with High Blood Pressure, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haidong Zhu, MD, PhD (706-721-4534, hzhu@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota diversity using 16s rRNA Sequencing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.