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

22 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

72

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny
        • Peking University
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Inny: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Inny: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Inny: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
Inny: High-Sodium Diet
Daily dietary salt intake: 12 g （sodium 200 mmol）
Inny: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Reproducibility of salt-sensitivity classification
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
The change in mean arterial pressure
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Home self-measured blood pressure
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peking University

Śledczy

  • Główny śledczy: Yifang Yuan, Peking University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 listopada 2026

Ukończenie studiów (Szacowany)

30 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

17 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1052-25187

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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