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

NCT07614724 | Not Yet Recruiting DMC

• 1 other identifier: 1052-25187
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Salt-Sensitivity of Blood Pressure; Hypertension

Keywords

blood pressure; salt-sensitivity

Outcome Measures

Primary Outcomes (1)

• Reproducibility of salt-sensitivity classification

  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

Secondary Outcomes (5)

• The change in mean arterial pressure

  Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42

• The change in systolic blood pressure

  Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42

• The change in diastolic blood pressure

  Salt-sensitivity test: baseline through Day 14 N-of-1 trial: baseline through Day 42

• Incidence of hypotension

  From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks

• The incidence of hyponalemia

  From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks

Other Outcomes (8)

• Home self-measured blood pressure

  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

  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

  From baseline of the salt-sensitivity test through the end of the n-of-1 trial, up to 8 weeks

Study Arms (2)

High-Sodium Diet

OTHER

Daily dietary salt intake: 12 g （sodium 200 mmol）

Other: High-Sodium Diet; Other: Low-Sodium Diet

Low-Sodium Diet

OTHER

Daily dietary salt intake: 5 g （sodium 85 mmol）

Other: High-Sodium Diet; Other: Low-Sodium Diet

Interventions

High-Sodium Diet OTHER

Daily dietary salt intake: 12 g （sodium 200 mmol）

High-Sodium Diet; Low-Sodium Diet

Low-Sodium Diet OTHER

Daily dietary salt intake: 5 g （sodium 85 mmol）

High-Sodium Diet; Low-Sodium Diet

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Yifang Yuan

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifang Yuan

CONTACT

0086-17310387323; yyfjulie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)