A Blood Pressure-Lowering Diet for Preventing and Managing Hypertension

Summary

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.

Conditions

• Hypertension

Interventions

BEHAVIORAL

Standard Hypertension Management

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.

BEHAVIORAL

Eastern Blood Pressure-Lowering Diet

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.

Sponsors & Collaborators

• Shengli Oilfield Hospital

  collaborator OTHER

• Peking University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2026-11-01

Completion

2027-11-01

Countries

• China

Study Locations