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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yifang Yuan
- Numéro de téléphone: 0086-17310387323
- E-mail: yyfjulie@163.com
Lieux d'étude
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Beijing, Chine
- Recrutement
- Peking University
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Contact:
- Yifang Yuan
- Numéro de téléphone: 0086-17310387323
- E-mail: yyfjulie@163.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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）
|
|
Autre: Low-Sodium Diet
Daily dietary salt intake: 5 g （sodium 85 mmol）
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Daily dietary salt intake: 12 g （sodium 200 mmol）
Daily dietary salt intake: 5 g （sodium 85 mmol）
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reproducibility of salt-sensitivity classification
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The change in mean arterial pressure
Délai: 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.
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Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42
|
|
The change in systolic blood pressure
Délai: 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
Délai: 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
|
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Incidence of hypotension
Délai: 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.
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From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
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The incidence of hyponalemia
Délai: 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.
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From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Home self-measured blood pressure
Délai: 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.
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From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
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The change in spot urine sodium
Délai: 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.
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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.
|
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Total sleep time during the study
Délai: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
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Measured using continuous wristband monitoring.
Total sleep time will be recorded in minutes per night.
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From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
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Number of nighttime awakenings during the study
Délai: From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
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Measured using continuous wristband monitoring.
The number of nighttime awakenings will be recorded as events per night.
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From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks
|
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Changes in mood parameters
Délai: 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.
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From baseline of the salt-sensitivity test through Day 42 of the n-of-1 trial, up to 8 weeks
|
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Fecal metabolites
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yifang Yuan, Peking University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1052-25187
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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