A Blood Pressure-Lowering Diet for Preventing and Managing Hypertension

Sponsor
Peking University
Study ID
NCT07735091
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Standard Hypertension Management — BEHAVIORAL
    Participants will receive standard hypertension management in accordance with current Chinese hypertension guidelines. Management includes routine clinical care, standardized health education on blood pressure control and healthy lifestyles, and antihypertensive medication when clinically indicated. Medication prescriptions and adjustments will be determined by the participants' treating physicians, and the study team will not directly modify clinical treatment. Participants will also complete study questionnaires and follow-up assessments through the study app and may wear a wearable device to record physical activity, heart rate, and sleep.
  • Eastern Blood Pressure-Lowering Diet — BEHAVIORAL
    Participants will receive a 3-month structured dietary intervention adapted to Chinese dietary habits in addition to standard hypertension management. Following a 1-week run-in period, standardized blood pressure-lowering lunches will be provided on working days by the workplace food-service center. Three meal energy levels, approximately 550-600, 650-750, or 800-900 kcal per lunch, will be assigned according to sex, age, body mass index, occupational physical activity, and regular exercise. The dietary pattern emphasizes reduced sodium intake, increased potassium intake, whole grains, legumes, tubers, vegetables, high-quality protein sources, healthier fats, and lower-fat cooking methods. Participants will also receive low-sodium salt, reduced-sodium condiments, and salt-measuring utensils for home use. Dietary adherence will be monitored through meal records and meal photographs submitted through the study app.

Study Details

This cluster-randomized controlled trial will evaluate whether a 3-month culturally adapted blood pressure-lowering dietary, called the Eastern Blood Pressure-Lowering Diet, can improve blood pressure and related health outcomes in Chinese adults with primary hypertension. Approximately 800 participants from 16 workplace-based clusters will be assigned to either a standard hypertension management group or a dietary intervention group. Both groups will receive usual hypertension care, including health education and medication treatment when clinically indicated. In addition, participants in the dietary intervention group will receive specially designed weekday lunches, low-sodium salt and reduced-sodium seasonings, and app-based support for dietary recording and adherence monitoring. The main outcome is change in resting systolic and diastolic blood pressure. Other outcomes include body weight, waist circumference, body fat, blood glucose, blood lipids, homocysteine, kidney function, estimated 24-hour urinary sodium and potassium excretion, lifestyle behaviors, sleep, psychological well-being, and the occurrence of hypertension-related complications or cardiovascular and cerebrovascular events. Blood, urine, and stool samples will also be analyzed to explore possible metabolic and gut microbiome mechanisms underlying the effects of the dietary intervention. The active dietary intervention will last 3 months, and participants will be followed for up to 24 months.

Key Dates

First listed
Jul 29, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2027

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Hypertension Management Group
    Participants will receive standard hypertension management in accordance with current Chinese hypertension guidelines, including routine clinical care, health education, and antihypertensive medication when clinically indicated. Medication decisions will remain under the responsibility of the participants' treating physicians. Participants will also use the study app for questionnaires, health education, dietary recording, and follow-up, and may wear a wearable device to record physical activity, heart rate, and sleep. They will not receive the structured Eastern Blood Pressure-Lowering Diet, workplace intervention lunches, or home sodium-reduction products.
  • Experimental: Eastern Blood Pressure-Lowering Diet Group
    Participants will receive the same standard hypertension management, routine clinical care, health education, app-based follow-up, and wearable-device monitoring as the active comparator group. In addition, they will receive a 3-month structured dietary intervention consisting of standardized blood pressure-lowering lunches provided on working days, with meal energy levels individualized according to sex, age, body mass index, occupational physical activity, and regular exercise. The dietary program emphasizes reduced sodium intake, increased potassium intake, whole grains, vegetables, high-quality protein, healthier fats, and lower-fat cooking methods. Participants will also receive low-sodium salt, reduced-sodium condiments, and salt-measuring utensils for use at home, with dietary adherence monitored through the study app.

Primary Outcome Measure

Resting Systolic Blood Pressure [ Time Frame: Baseline and 3 month after baseline survey ]

Central Contacts

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