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The effect of Tegusi/selenium enriched probiotics combined with exercise on hypertension: a randomized controlled trial

The effect of Tegusi/selenium enriched probiotics combined with exercise on hypertension: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089602
Enrollment
Unknown
Registered
2024-09-11
Start date
2024-04-19
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

Control group:The control group receives traditional medication treatment and health education.
Diet and exercises group:In addition to receiving traditional medication and health education, the diet and exercises group also receives balanced dietary guidance and exercises.
Diet, probiotics, and exercises group:In addition to receiving traditional medication treatment and health education, the diet, probiotics, and exercises group also receives balanced dietary guidance,

Sponsors

School of Public Health, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of primary hypertension. The patient has a systolic blood pressure of = 125 mmHg and/or diastolic blood pressure of = 75 mmHg in the clinic three times on different days without using antihypertensive drugs. 2. Age: 30 to 70 years old. 3. Willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Previous history of cardiovascular diseases, including angina, myocardial infarction, heart failure, acute cardiovascular events (such as acute coronary syndrome, coronary artery revascularization surgery, stroke) in the previous year, peripheral arterial disease, ventricular arrhythmias, atrial fibrillation, hypertrophic cardiomyopathy, aortic aneurysm diameter = 5.5 cm, or history of aortic aneurysm surgery; 3. Cirrhosis, liver failure, renal failure, chronic obstructive pulmonary disease, musculoskeletal disease, any gastrointestinal disease; 4; Participants participated in other clinical trials related to the treatment of hypertension in the past year; 5. Participants changed their antihypertensive medication three months prior to inclusion in the study; 6. Active malignant tumors or a history of malignant tumors within the past 5 years; 7. Participants are unable to follow recommended diets (due to religious reasons, swallowing disorders, etc.); 8. Restrict physical activities or participate in regular exercise and training; 9. Participants habitually consume more grains and supplement with probiotics; 10. Allergies to dietary interventions and food ingredients; 11. Immunodeficiency or HIV positive status; 12. Mental illnesses, including schizophrenia, bipolar disorder, eating disorders, and depression; 13. Any serious comorbidities with a life expectancy of less than 24 months; 14. Excessive drinking or drug abuse; 15. History of organ transplantation; 16. Currently using weight loss pills; 17. Pregnancy or planned pregnancy.

Design outcomes

Primary

MeasureTime frame
Blood pressure;Ambulatory blood pressure;

Secondary

MeasureTime frame
BMI;Waist circumference;Body composition;Ultrasound;Gut microbiota sequencing;Blood parameters;Urine parameters;

Countries

China

Contacts

Public ContactMin Zhao

Department of Nutrition and Food Hygiene, School of Public Health, Shandong University

zhaomin1986zm@126.com+86 158 5319 3469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026