HypertensionNCT04648592
Salt Intake, Microbiota, Immune Response and Endothelial Function in Hypertension
A study testing Low salt diet plus sodium chloride supplements in people with Hypertension, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial summary
Hypertension is a significant cardiovascular risk factor which affects 45% of the adult population. Salt intake is essential in the development and progression of hypertension. A reduction in salt intake is associated with a reduction in blood pressure and a 25% lower risk of suffering a cardiovascular event. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Low salt diet plus sodium chloride supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to 30 Apr 2022
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of primary hypertension on treatment for at least 12 months with an ACEI or ARB-II in monotherapy.
- Able to understand the study objectives and to provide written informed consent.
Who cannot join
- Severe hypertension, defined as a sitting systolic blood pressure ≥200 mmHg, a sitting diastolic blood pressure ≥115 mmHg or a maximum-minimum difference of ≥20 mmHg in systolic blood pressure or ≥10 mmHg in diastolic blood pressure between the right and left arms after three measurements on each arm.
- Suggestive symptoms of secondary hypertension, such as abrupt onset hypertension, age <30 years, advanced end organ damage, new-onset diastolic hypertension in the elderly,
- Treated with antihypertensive drugs other than ACEIs or ARBs.
- Use of drugs that affect diuresis or natriuresis.
- Poorly controlled type 1 or 2 diabetes, defined as a fasting blood glucose ≥200 mg/dl or HbA1c ≥9%.
- History of cardiovascular disease, defined as acute myocardial infarction, ischemic transient attack or stroke, congestive heart failure, peripheral vascular disease or cardiac arrhythmias.
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- Chronic obstructive pulmonary disease.
- Liver or kidney disease.
- Pregnant or lactating women.
- Legal incapacity or impossibility to understand the study objectives.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario
Valladolid, 47003
Armando Coca, MD, PhD, 630841439, a.coca.rojo@gmail.com
Armando Coca, MD, PhD
About this study
Official title: Impact of Salt Intake on Gut Microbiota, Th17 Immune Response and Endothelial Function in Hypertensive Patients
Hypertension is a significant cardiovascular risk factor which affects 45% of the adult population. Salt intake is essential in the development and progression of hypertension. A reduction in salt intake is associated with a reduction in blood pressure and a 25% lower risk of suffering a cardiovascular event. The mechanisms involved in the association between salt intake and blood pressure are a topic of discussion. Increased salt intake can modify cardiovascular function, inducing endothelial dysfunction, modyfing the activity of the immune system and increasing inflammation or oxidative stress.
In recent years, dietary salt intake has been linked to intestinal depletion of certain genera of bacteria such as Lactobacillus. Tryptophan metabolites formed by these bacteria have been shown to modulate the activity of pro-inflammatory cells such as Th17/CD4+, interleukin 17a producing cells. Studies in animal models have demonstrated that interleukin 17a is able to raise blood pressure by hindering endothelium-dependent vasodilation mechanisms. It is also able to cause sodium and water retention, increase albuminuria, induce renal microvascular injury and vasoconstriction and promote vascular stiffening, cardiac hypertrophy and fibrosis.
The main objective of this trial is to describe the relationship between salt intake, gut commensal microbiota, Th17 activity, endothelial dysfunction and blood pressure evolution in a sample of patients with essential hypertension.
- Conditions
- Hypertension
- Being tested
- Low salt diet plus sodium chloride supplements, Low salt diet plus placebo
- Keywords
- Hypertension, Salt intake
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low salt diet plus sodium chloride supplementsDietary supplement
Also called Salt
Patients will receive a low salt diet plus salt supplements.
Low salt diet plus placeboDietary supplement
Also called Placebo
Patients will receive a low salt diet plus placebo.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Low salt diet, aiming at a daily sodium intake of 50 mmol plus oral salt supplements (9 grams) to achieve an overall daily sodium intake of 200 mmol. Receives: Dietary Supplement: Low salt diet plus sodium chloride supplements |
| Control | Placebo comparator | Low salt diet, aiming at a daily sodium intake of 50 mmol plus oral placebo supplements to achieve an overall daily sodium intake of 50 mmol. Receives: Dietary Supplement: Low salt diet plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in lymphocyte subset counts
Lymphocyte subset counts
Measured: 30 days
Secondary outcomes (4)
Relative change in gut microbiota composition daily total salt
Taxonomic metagenomic analysis, analyzing the composition at the level of family, genus and species. Percentage of variation of each species in each control.
Measured: 30 days
Relative change in body composition assessed by electrical bioimpedance
Percentage of change in total body water, total intracellular water, total extracellular water, fat mass, percentage of fat, lean mass, and muscle-skeletal mass.
Measured: 30 days
Absolute change in peak and average 24h ambulatory blood pressure measurement
24h ambulatory blood pressure measurement
Measured: 30 days
Absolute change in endothelial function
Pulse wave velocity analysis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, double blind clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Coca Rojo, Hospital Clínico Universitario de Valladolid
- Investigators
- Armando Coca, MD, MSc, phD, Principal investigator, Hospital Clínico Universitario Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648592
- Sponsor's protocol ID
- PI 19-1342
- Status last verified
- Feb 2021
- First submitted
- 23 Nov 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Salt Intake on Gut Microbiota, Th17 Immune Response and Endothelial Function in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04648592
- Acronym / sponsor ID
- PI 19-1342
- Conditions
- Hypertension
- Keywords
- Hypertension, Salt intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 1 Dec 2020 (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.
Hypertension is a significant cardiovascular risk factor which affects 45% of the adult population. Salt intake is essential in the development and progression of hypertension. A reduction in salt intake is associated with a reduction in blood pressure and a 25% lower risk of suffering a cardiovascular event. The mechanisms involved in the association between salt intake and blood pressure are a topic of discussion. Increased salt intake can modify cardiovascular function, inducing endothelial dysfunction, modyfing the activity of the immune system and increasing inflammation or oxidative stress.
In recent years, dietary salt intake has been linked to intestinal depletion of certain genera of bacteria such as Lactobacillus. Tryptophan metabolites formed by these bacteria have been shown to modulate the activity of pro-inflammatory cells such as Th17/CD4+, interleukin 17a producing cells. Studies in animal models have demonstrated that interleukin 17a is able to raise blood pressure by hindering endothelium-dependent vasodilation mechanisms. It is also able to cause sodium and water retention, increase albuminuria, induce renal microvascular injury and vasoconstriction and promote vascular stiffening, cardiac hypertrophy and fibrosis.
The main objective of this trial is to describe the relationship between salt intake, gut commensal microbiota, Th17 activity, endothelial dysfunction and blood pressure evolution in a sample of patients with essential hypertension.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Low salt diet plus sodium chloride supplementsLow salt diet, aiming at a daily sodium intake of 50 mmol plus oral salt supplements (9 grams) to achieve an overall daily sodium intake of 200 mmol. |
| Control | Placebo comparator | Dietary Supplement: Low salt diet plus placeboLow salt diet, aiming at a daily sodium intake of 50 mmol plus oral placebo supplements to achieve an overall daily sodium intake of 50 mmol. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Diagnosis of primary hypertension on treatment for at least 12 months with an ACEI or ARB-II in monotherapy.
- Able to understand the study objectives and to provide written informed consent.
Key exclusion criteria (10 listed)
- Severe hypertension, defined as a sitting systolic blood pressure ≥200 mmHg, a sitting diastolic blood pressure ≥115 mmHg or a maximum-minimum difference of ≥20 mmHg in systolic blood pressure or ≥10 mmHg in diastolic blood pressure between the right and left arms after three measurements on each arm.
- Suggestive symptoms of secondary hypertension, such as abrupt onset hypertension, age <30 years, advanced end organ damage, new-onset diastolic hypertension in the elderly,
- Treated with antihypertensive drugs other than ACEIs or ARBs.
- Use of drugs that affect diuresis or natriuresis.
- Poorly controlled type 1 or 2 diabetes, defined as a fasting blood glucose ≥200 mg/dl or HbA1c ≥9%.
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 |
|---|---|---|
| Low salt diet plus sodium chloride supplementsAlso: SaltPatients will receive a low salt diet plus salt supplements. | Dietary supplement | Intervention |
| Low salt diet plus placeboAlso: PlaceboPatients will receive a low salt diet plus placebo. | Dietary supplement | Control |
Primary outcome
Absolute change in lymphocyte subset counts
Time frame: 30 days
Lymphocyte subset counts
4 secondary outcomes
Relative change in gut microbiota composition daily total salt
Time frame: 30 days
Relative change in body composition assessed by electrical bioimpedance
Time frame: 30 days
Absolute change in peak and average 24h ambulatory blood pressure measurement
Time frame: 30 days
Absolute change in endothelial function
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No. Study data will be shared upon reasonable request.
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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.
Armando Coca, MD, MSc, phD principal investigator
Hospital Clínico Universitario Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low salt diet plus sodium chloride supplements in people with Hypertension, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
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 3 inclusion and 10 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 Feb 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 Spain. 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.
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 Armando Coca, MD, MSc, phD (983420000, a.coca.rojo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in lymphocyte subset counts (time frame: 30 days). 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 Feb 2021.