A Blood Pressure-Lowering Diet for Preventing and Managing Hypertension

NCT07735091 | Not Yet Recruiting

• 1 other identifier: IRB00001052-26081
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Feeding Trials; Hypertension; Cluster-Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Resting Systolic Blood Pressure

  Resting systolic blood pressure will be measured in millimeters of mercury (mmHg) by trained study personnel using a validated and regularly calibrated upper-arm electronic blood pressure monitor. Participants will rest in a seated position for at least 5 to 10 minutes before measurement. At least two measurements will be taken 30 to 60 seconds apart. If the difference between the first two readings exceeds 10 mmHg, a third measurement will be obtained. The mean of the valid readings will be used. The outcome is the change from baseline to the end of the 3-month intervention.

  Baseline and 3 month after baseline survey

• Resting Diastolic Blood Pressure

  Resting diastolic blood pressure will be measured in millimeters of mercury (mmHg) using the same standardized procedure as systolic blood pressure. At least two measurements will be obtained after seated rest, and the mean of the valid readings will be used. The outcome is the change from baseline to the end of the 3-month intervention.

  Baseline and 3 months after baseline survey

Secondary Outcomes (18)

• Body Weight

  Baseline& 3 months, 12 months, and 24 months after baseline survey

• Height

  Baseline& 3 months, 12 months, and 24 months after baseline survey

• Body Mass Index

  Baseline& 3 months, 12 months, and 24 months after baseline survey

• Waist Circumference

  Baseline& 3 months, 12 months, and 24 months after baseline survey

• Body Fat Percentage

  Baseline& 3 months, 12 months, and 24 months after baseline survey

Other Outcomes (8)

• Change in Gut Microbial Alpha Diversity Assessed by Stool Metagenomic Sequencing

  Baseline and 3 months after Baseline Survey

• Change in Gut Microbial Beta Diversity Assessed by Stool Metagenomic Sequencing

  Baseline and 3 months after Baseline Survey

• Change in Relative Abundance of Gut Microbial Taxa Assessed by Stool Metagenomic Sequencing

  Baseline and 3 months after Baseline Survey

Study Arms (2)

Standard Hypertension Management Group

ACTIVE COMPARATOR

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.

Behavioral: Standard Hypertension Management

Eastern Blood Pressure-Lowering Diet Group

EXPERIMENTAL

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.

Behavioral: Eastern Blood Pressure-Lowering Diet

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.

Standard Hypertension Management Group

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.

Eastern Blood Pressure-Lowering Diet Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 60 years.
• Employed by Shengli Oilfield and regularly receiving meals from a participating workplace canteen.
• Regularly eats at the participating canteen, generally on at least 4 working days per week.
• Diagnosed with primary hypertension by a qualified medical institution, or meets the diagnostic criterion of systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg on 3 measurements obtained on different days.
• Hypertension is clinically stable.
• Antihypertensive medication regimen is stable, when applicable.
• Able and willing to comply with the dietary intervention, study assessments, and follow-up procedures.
• Provides written informed consent voluntarily.

You may not qualify if:

• Secondary hypertension.
• Pregnancy, breastfeeding, or planning to become pregnant during the study period.
• Serious food allergy or intolerance to major foods included in the intervention diet, such as nuts, dairy products, or gluten-containing foods.
• Major cardiovascular or cerebrovascular event within the previous 6 months, such as myocardial infarction or stroke.
• Severe cardiopulmonary disease, such as heart failure or severe asthma.
• Cancer, advanced kidney disease, severe liver disease, or another serious medical condition.
• A medical condition requiring a specialized therapeutic diet that would interfere with the study intervention.
• Severe psychiatric illness.
• Severe cognitive impairment that prevents understanding of the informed consent form or compliance with study procedures.
• Hearing impairment or physical disability that would substantially interfere with participation.
• Any other condition that, in the judgment of the research team, makes the individual unsuitable for participation.

Sponsors & Collaborators

• Peking University: lead
• Shengli Oilfield Hospital: collaborator

Study Sites (1)

Sinopec Shengli Petroleum Administrative Bureau Co., Ltd.

Dongying, Shandong, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jiashu Li, Dr.

CONTACT

+86 - 15811092075; jiashu.li@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)