Health TrialsbyHealthPanel

A Blood Pressure-Lowering Diet for Preventing and Managing Hypertension

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Standard Hypertension Management GroupActive comparator 1 intervention
Group B: Eastern Blood Pressure-Lowering Diet GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 3 month after baseline survey
2

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.

Time frame
Baseline and 3 months after baseline survey

Secondary outcomes

1

Body Weight

Body Weight will be measured using weight (Type: Inbody 120), with participants wearing light clothing and no shoes.

Time frame
Baseline& 3 months, 12 months, and 24 months after baseline survey
2

Height

Body height will be measured with a ruler

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

Body Mass Index

Body weight and height will be combined to report BMI in kg/m\^2

Time frame
Baseline& 3 months, 12 months, and 24 months after baseline survey
4

Waist Circumference

Waist Circumference will be measured with a ruler in centimeter

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

Other outcomes

1

Change in Gut Microbial Alpha Diversity Assessed by Stool Metagenomic Sequencing

Stool samples will undergo metagenomic sequencing. Gut microbial alpha diversity will be assessed using prespecified diversity indices, including Shannon diversity and other relevant alpha diversity metrics. Changes from baseline to 3 months after baseline survey will be compared between study groups.

Time frame
Baseline and 3 months after Baseline Survey
2

Change in Gut Microbial Beta Diversity Assessed by Stool Metagenomic Sequencing

Stool samples will undergo metagenomic sequencing. Gut microbial beta diversity will be evaluated using prespecified distance metrics to assess differences in microbial community composition between baseline and 3 months after baseline survey.

Time frame
Baseline and 3 months after Baseline Survey
3

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

Stool samples will undergo metagenomic sequencing. Relative abundance changes of prespecified microbial taxa will be analyzed at different taxonomic levels, including phylum, family, genus, and species levels when applicable.

Time frame
Baseline and 3 months after Baseline Survey
4

Change in Gut Microbial Functional Pathway Abundance Assessed by Stool Metagenomic Sequencing

Stool samples will undergo metagenomic sequencing. Changes in microbial functional pathways will be assessed using annotated metagenomic functional databases. Prespecified pathway abundance profiles will be compared between baseline and 3 months after baseline survey.

Time frame
Baseline and 3 months after Baseline Survey

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University

Lead sponsor

Shengli Oilfield Hospital

Collaborator

Source ClinicalTrials.gov

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