Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

22. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

72

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Yifang Yuan
  • Telefonní číslo: 0086-17310387323
  • E-mail: yyfjulie@163.com

Studijní místa

  • Čína
      • Beijing, Čína
        • Peking University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Jiný: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Jiný: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Jiný: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Jiný: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Jiný: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reproducibility of salt-sensitivity classification
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The change in mean arterial pressure
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Home self-measured blood pressure
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Peking University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yifang Yuan, Peking University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

30. listopadu 2026

Dokončení studie (Odhadovaný)

30. listopadu 2026

Termíny zápisu do studia

První předloženo

17. května 2026

První předloženo, které splnilo kritéria kontroly kvality

22. května 2026

První zveřejněno (Aktuální)

29. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1052-25187

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na High-Sodium Diet

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Panama

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit