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Salt Sensitivity Evaluation Via N-of-1 Trials (SENSE-Salt) (SENSE-Salt)

22 maggio 2026 aggiornato da: Peking University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

  1. Primary Objective: To assess whether there are differences in blood pressure responses between salt-sensitive and salt-resistant individuals.
  2. 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:

  1. 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).
  2. 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Yifang Yuan
  • Numero di telefono: 0086-17310387323
  • Email: yyfjulie@163.com

Luoghi di studio

  • Cina
      • Beijing, Cina
        • Peking University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Phase 1: Salt Sensitivity Screening

Inclusion:

  1. Signed informed consent for the salt sensitivity test.
  2. Systolic blood pressure between 110-159 mmHg and diastolic blood pressure between 70-99 mmHg.
  3. 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.
  4. Able to comply with consuming the study-provided diet throughout the study period.

Exclusion:

  1. 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.
  2. 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.
  3. Experienced acute myocardial infarction or stroke within the past 6 months.
  4. Acute illnesses such as upper respiratory tract infection, fever, or severe diarrhea that have not yet resolved.
  5. Alcohol abuse.
  6. Pregnant or breastfeeding women, or women planning to become pregnant.
  7. Individuals who are deaf, mute, or have cognitive impairments that hinder communication.

Phase 2: N-of-1 Trial

Inclusion:

  1. Classified as salt-sensitive or salt-resistant through the Phase 1 screening:
  2. 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.
  3. 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.
  4. Signed informed consent for the n-of-1 trial.

Exclusion:

  1. 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).
  2. Experienced adverse events during the salt sensitivity test that, in the investigator's judgment, make it inappropriate to continue in the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Altro: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Altro: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Altro: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Altro: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Altro: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reproducibility of salt-sensitivity classification
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The change in mean arterial pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Home self-measured blood pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University

Investigatori

  • Investigatore principale: Yifang Yuan, Peking University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

17 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1052-25187

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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