NCT04403347Completed
Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention
Effect of Tartary Buckwheat Diet Intervention on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
Mounting preclinical and clinical evidences have proved the optimal role of diets (i.e. DASH (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a causal role of gut microbiota on the pathogenesis of primary hypertension. Dietary changes appeared to reshape gut microbiota and to ameliorate diseases such as Type 2 Diabetes. A hypothesis is thus raised that dietary changes can be a potential approach to ameliorate hypertension via gut microbiome restoration. This pilot study will utilize an innovative natural dietary formulation (patent ID: CN110250417A) derived from Tartary buckwheat(TBW) diet, in comparison with usual care (guideline-based patient education and lifestyle recommendations), to investigate its effect and safety on primary hypertension treatment, and the underlying mechanisms of gut microbiome restoration.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 20 May 2020
- Start date
- 8 Jul 2021
- Primary completion date
- 14 Aug 2024
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Diseases
- High blood pressure
- NCT number
- NCT04403347
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 8 Jul 2021 to the primary completion date, 14 Aug 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antihypertensive medications usage currently or within last month
Other illness
- Participants of other clinical trials related to hypertension currently or within last 3 months
- Diagnosed secondary hypertension
- History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack \[TIA\])
- Hospitalization for myocardial infarction within last 6 months; Coronary revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the next 12 months.
- Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement.
- NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months.
- Severe valvular diseases; Potential for surgery or percutaneous valve replacement within the study period.
- Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease; Congenital heart disease.
- Other severe diseases influencing the entry or survival of participants, such as malignant tumor or acquired immune deficiency syndrome.
- Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent.
- Other conditions inappropriate for recruitment according to the investigators.
Lab values
- Severe hepatic or renal diseases ((ALT \>3 times the upper limit of normal value, or end stage renal disease on dialysis or eGFR \<30 mL/min/1.73 m2, or serum creatinine \>2.5 mg/dl \[\>221 μmol/L\])
Other
- Antibiotics or probiotics usage within last 4 weeks
- Participants preparing for or under pregnancy and/or lactation.
Who the study is looking for
- Age 18\~60 years.
- Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from antihypertensive drugs within a month): 140mmHg≤ Office SBP\<160mmHg for three measurements at different days without any antihypertensive medications, according to the "2010 Chinese Guidelines for Prevention and Treatment of Hypertension".
- Patients with informed consent after thorough explanation.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Pinggu Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Clinical Medical College&Affiliated Hospital of Chengdu University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Second Affiliated Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Longgang District People's Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| the People's Hospital of Ji Xian District Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.