Salt Sensitivity Evaluation Via N-of-1 Trials (SENSE-Salt)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorPeking University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
High-Sodium Diet
Other interventionDaily dietary salt intake: 12 g （sodium 200 mmol）
Low-Sodium Diet
Other interventionDaily dietary salt intake: 5 g （sodium 85 mmol）
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: High-Sodium DietOther 2 interventions
Group B: Low-Sodium DietOther 2 interventions
Trial outcomes
Primary outcomes
1
Reproducibility of salt-sensitivity classification
The proportion of participants with concordant salt-sensitivity classification across repeated assessments
Time frame
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42Secondary outcomes
1
The change in mean arterial pressure
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.
Time frame
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 422
The change in systolic blood pressure
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.
Time frame
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 423
The change in diastolic blood pressure
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.
Time frame
Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 424
Incidence of hypotension
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.
Time frame
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeksOther outcomes
1
Home self-measured blood pressure
Home self-measured blood pressure is defined as the values obtained by participants using the electronic sphygmomanometer provided by the research team.
Time frame
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks2
The change in spot urine sodium
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.
Time frame
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.3
Total sleep time during the study
Measured using continuous wristband monitoring. Total sleep time will be recorded in minutes per night.
Time frame
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks4
Number of nighttime awakenings during the study
Measured using continuous wristband monitoring. The number of nighttime awakenings will be recorded as events per night.
Time frame
From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeksSponsors and contacts
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Source ClinicalTrials.gov