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

22. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Beijing, China
        • Peking University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Sonstiges: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Sonstiges: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Sonstiges: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Sonstiges: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Sonstiges: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reproducibility of salt-sensitivity classification
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The change in mean arterial pressure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Home self-measured blood pressure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking University

Ermittler

  • Hauptermittler: Yifang Yuan, Peking University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. November 2026

Studienabschluss (Geschätzt)

30. November 2026

Studienanmeldedaten

Zuerst eingereicht

17. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Mai 2026

Zuerst gepostet (Tatsächlich)

29. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1052-25187

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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