Salt Sensitivity Evaluation Via N-of-1 Trials (SENSE-Salt) (SENSE-Salt)
Determining the Presence of Salt Sensitivity in Individuals With Elevated Blood Pressure Through Dietary Salt Interventions: A Series of N-of-1 Trials
Study Title: Determining the Presence of Salt Sensitivity in Individuals With Elevated Blood Pressure Through Dietary Salt Interventions: A Series of N-of-1 Trials
Objective: To evaluate whether there are differences in blood pressure responses to dietary sodium intake between salt-sensitive and salt-resistant individuals, as identified through a salt sensitivity test. The study will use repeated dietary interventions with varying sodium content (high-sodium, low-sodium) to assess blood pressure responses in each individual, aiming to determine whether salt sensitivity is a present characteristic.
Study Design: This study will utilize an N-of-1 randomized controlled trial design. It consists of two phases:
Salt Sensitivity Screening: A 2-week chronic salt-loading test will be used to identify salt-sensitive and salt-resistant individuals.
N-of-1 Trial: The identified salt-sensitive and salt-resistant individuals will undergo a 6-week N-of-1 trial, consisting of three cycles, with each cycle including one week of low-sodium diet and one week of high-sodium diet. This design aims to assess individual blood pressure responses to changes in sodium intake.
Sample Size: A total of 72 participants will be recruited for the salt sensitivity screening, with an expected 24 participants proceeding to the N-of-1 trial.
Study Population: Healthy individuals aged 20-65 years, not on antihypertensive medication or with a stable regimen for at least 3 months, with systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg, who are able to eat at the research center.
Primary Outcome: Reproducibility of salt sensitivity response classification. Secondary Outcomes: Changes in mean arterial pressure, systolic and diastolic blood pressure; exploratory outcomes such as sleep, mood, gut microbiome, metabolomics; safety outcomes including hypotension and hyponatremia.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Study Title: Determining the Presence of Salt Sensitivity in Individuals With Elevated Blood Pressure Through Dietary Salt Interventions: A Series of N-of-1 Trials
Objective:
- Primary Objective: To assess whether there are differences in blood pressure responses between salt-sensitive and salt-resistant individuals.
- Exploratory Objectives: To explore the effects of different sodium-content diets on individual pulse, sleep, and mood; to evaluate whether a low-sodium diet increases the incidence of hypotension; and to identify metabolic differences associated with salt sensitivity.
Study Design: This study will utilize a two-phase N-of-1 randomized controlled trial design. It consists of the following phases:
- Salt Sensitivity Screening: Participants will undergo a 2-week dietary intervention (1 week of high-sodium diet: 200 mmol/day; 1 week of low-sodium diet: 85 mmol/day). Salt sensitivity will be determined by comparing changes in mean arterial pressure (MAP) between the high-sodium and low-sodium periods (△MAP). Individuals with △MAP ≥5 mmHg and in the upper 1/6 of the population will be classified as salt-sensitive (SS), while those with △MAP <5 mmHg and in the lower 1/6 will be classified as salt-resistant (SR).
- N-of-1 Trial: The identified salt-sensitive and salt-resistant individuals will undergo a 6-week N-of-1 trial, consisting of three cycles. Each cycle will last 2 weeks (1 week of high-sodium diet and 1 week of low-sodium diet). This design aims to assess individual blood pressure responses to changes in sodium intake.
Sample Size: A total of 72 participants will be recruited for the salt sensitivity screening, with an expected 24 participants proceeding to the N-of-1 trial.
Study Population: Healthy individuals aged 20-65 years, not on antihypertensive medication or with a stable regimen for at least 3 months, with systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg, who are able to eat at the research center.
Primary Outcome: Reproducibility of salt sensitivity response classification. Secondary Outcomes:Changes in mean arterial pressure, systolic and diastolic blood pressure; exploratory outcomes such as sleep, mood, gut microbiome, and metabolomics; and safety outcomes including hypotension and hyponatremia.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Yifang Yuan
- Telefonnummer: 0086-17310387323
- E-post: yyfjulie@163.com
Studieorter
-
-
-
Beijing, Kina
- Rekrytering
- Peking University
-
Kontakt:
- Yifang Yuan
- Telefonnummer: 0086-17310387323
- E-post: yyfjulie@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Phase 1: Salt Sensitivity Screening
Inclusion:
- Signed informed consent for the salt sensitivity test.
- Systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg.
- Not taking any antihypertensive medication, or have had a stable antihypertensive regimen for the past three months and agree not to adjust their medication during the study period.
- Able to comply with consuming the study-provided diet throughout the study period.
Exclusion:
- Special dietary requirements, such as allergies to common foods (e.g., eggs, seafood, peanuts), or conditions like asthma, irritable bowel syndrome, lactose intolerance, chronic kidney disease stage 4 or higher, history of gastrointestinal surgery, or special dietary needs due to other illnesses, surgery, or weight loss.
- Diagnosed with chronic diseases: any malignancy with a life expectancy of less than one year; chronic heart failure, severe depression or other mental disorders, long-term bedridden status, or mobility limitations.
- Experienced acute myocardial infarction or stroke within the past 6 months.
- Acute illnesses such as upper respiratory tract infection, fever, or severe diarrhea that have not yet resolved.
- Alcohol abuse.
- Pregnant or breastfeeding women, or women planning to become pregnant.
- Individuals who are deaf, mute, or have cognitive impairments that hinder communication.
Phase 2: N-of-1 Trial
Inclusion:
- Classified as salt-sensitive or salt-resistant through the Phase 1 screening:
- Salt-Sensitive (SS) Group: Participants with a change in mean arterial pressure (ΔMAP) ≥ 5 mmHg and in the upper 1/6 of the distribution of ΔMAP from the salt sensitivity test.
- Salt-Resistant (SR) Group: Participants with a change in mean arterial pressure (ΔMAP) < 5 mmHg and in the lower 1/6 of the distribution of ΔMAP from the salt sensitivity test.
- Signed informed consent for the n-of-1 trial.
Exclusion:
- Failed to complete the salt sensitivity test as required, or consumed less than 80% of the study-provided meals during the salt sensitivity test (i.e., fewer than 34 meals over 14 days).
- Experienced adverse events during the salt sensitivity test that, in the investigator's judgment, make it inappropriate to continue in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
|
Daily dietary salt intake: 12 g （sodium 200 mmol）
Daily dietary salt intake: 5 g （sodium 85 mmol）
|
|
Övrig: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
|
Daily dietary salt intake: 12 g （sodium 200 mmol）
Daily dietary salt intake: 5 g （sodium 85 mmol）
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reproducibility of salt-sensitivity classification
Tidsram: Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
The proportion of participants with concordant salt-sensitivity classification across repeated assessments
|
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The change in mean arterial pressure
Tidsram: Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
the change in mean arterial pressure (MAP) is defined as the difference between the mean follow-up MAP during the high-sodium period and the mean follow-up MAP during the low-sodium period.
|
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
|
The change in systolic blood pressure
Tidsram: Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
the change in systolic blood pressure (SBP) is defined as the difference between the mean follow-up SBP during the high-sodium period and the mean follow-up SBP during the low-sodium period.
|
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
|
The change in diastolic blood pressure
Tidsram: Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
the change in diastolic blood pressure (DBP) is defined as the difference between the mean follow-up DBP during the high-sodium period and the mean follow-up DBP during the low-sodium period.
|
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
|
Incidence of hypotension
Tidsram: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
Hypotension is defined as at least two blood pressure readings <90/60 mm Hg during follow-up, or symptomatic hypotension diagnosed by a physician during treatment.
|
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
|
The incidence of hyponalemia
Tidsram: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
A new case of hyponalemia is defined as having serum sodium<135 mmol/L in any follow-up or during the study period with normal serum sodium at the baseline, regardless of clinical manifestations.
|
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Home self-measured blood pressure
Tidsram: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
Home self-measured blood pressure is defined as the values obtained by participants using the electronic sphygmomanometer provided by the research team.
|
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
|
The change in spot urine sodium
Tidsram: Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
the change in spot urine sodium is defined as the difference between the mean follow-up urine sodium during the high-sodium period and the mean follow-up urine sodium during the low-sodium period.
|
Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
|
Total sleep time during the study
Tidsram: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
Measured using continuous wristband monitoring.
Total sleep time will be recorded in minutes per night.
|
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
|
Number of nighttime awakenings during the study
Tidsram: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
Measured using continuous wristband monitoring.
The number of nighttime awakenings will be recorded as events per night.
|
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
|
Changes in mood parameters
Tidsram: From baseline of the salt-sensitivity test through Day 42 of the n-of-1 trial, up to 8 weeks
|
Measured with the Center for Epidemiologic Studies Depression Scale-10 item version (CESD-10).
The total score ranges from 0 to 30, with higher scores indicating worse depressive symptoms/mood status.
|
From baseline of the salt-sensitivity test through Day 42 of the n-of-1 trial, up to 8 weeks
|
|
Fecal metabolites
Tidsram: Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
Fecal metabolomic profiles will be analyzed using liquid chromatography-quadrupole time-of-flight mass spectrometry (LC-QTOF-MS).
|
Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
|
Fecal microbiota
Tidsram: Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
Gut microbial composition and functional features will be assessed using shotgun metagenomic sequencing of fecal samples.
|
Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
|
Metabolomics profiling
Tidsram: Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
Metabolomic profiling will be performed using urine and fecal samples collected during follow-up.
Baseline serum samples will also be included in the metabolomic analyses.
|
Salt-sensitivity test: baseline, day 7, day 14 follow-up. N of 1 trial: baseline, day 7, day 14, day 21, day 28, day 35, day 42 follow-up.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yifang Yuan, Peking University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1052-25187
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .