Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention

Last updated: January 12, 2026
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

High Blood Pressure (Hypertension)

High Blood Pressure (Hypertension - Pediatric)

Treatment

Innovative Dietary Formulation (Patent ID: CN110250417A)

Regular Diet

Clinical Study ID

NCT04403347
2017-GZ10 (Part II)
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18~60 years.

  2. Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free fromantihypertensive drugs within a month): 140mmHg≤ Office SBP<160mmHg for threemeasurements at different days without any antihypertensive medications, accordingto the "2010 Chinese Guidelines for Prevention and Treatment of Hypertension".

  3. Patients with informed consent after thorough explanation.

Exclusion

Exclusion Criteria:

  1. Antibiotics or probiotics usage within last 4 weeks

  2. Participants of other clinical trials related to hypertension currently or withinlast 3 months

  3. Antihypertensive medications usage currently or within last month

  4. Diagnosed secondary hypertension

  5. Severe hepatic or renal diseases ((ALT >3 times the upper limit of normal value, orend stage renal disease on dialysis or eGFR <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dl [>221 μmol/L])

  6. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (notincluding lacunar infarction and transient ischemic attack [TIA])

  7. Hospitalization for myocardial infarction within last 6 months; Coronaryrevascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG inthe next 12 months.

  8. Sustained atrial fibrillation or arrhythmias at recruitment disturbing theelectronic BP measurement.

  9. NYHA class III-IV heart failure; Hospitalization for chronic heart failureexacerbation within last 6 months.

  10. Severe valvular diseases; Potential for surgery or percutaneous valve replacementwithin the study period.

  11. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease;Congenital heart disease.

  12. Other severe diseases influencing the entry or survival of participants, such asmalignant tumor or acquired immune deficiency syndrome.

  13. Cognitive impairment or severe neuropsychiatric comorbidities who are incapable ofproviding their own informed consent.

  14. Participants preparing for or under pregnancy and/or lactation.

  15. Other conditions inappropriate for recruitment according to the investigators.

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Innovative Dietary Formulation (Patent ID: CN110250417A)
Phase:
Study Start date:
July 08, 2021
Estimated Completion Date:
September 12, 2024

Study Description

Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global public health issue because of the high morbidity and potential risk to other cardiovascular diseases. Several animal studies and diverse patient cohorts reported that the disorder of gut microbiome correlated with hypertension. Based on the investigators' previous work findings of metagenomics analysis, fecal transplantation and metabolomics changes in hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was observed in primary hypertension and raised a hypothesis that gut microbiome restoration can be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics, probiotics, dietary changes and other methodologies can assist gut microbiome restoration in diseases such as type 2 diabetes. The investigators therefore develop two pilot studies respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot Study II) to explore the methodologies, effect, safety and underlying mechanisms of gut microbiome restoration on hypertension. These pilot studies also present as the clinical translational part of the research project "The Role of Gut Microbiome in the Pathogenesis of Essential Hypertension"(Project ID 81630014, sponsored by National Natural Science Foundation of China).

This study is the Pilot Study II:

Objective: With reference of DASH diet and Mediterranean diet, this study aims to explore the effect and safety of an innovative natural dietary formulation (deriving from TBW diet) on primary hypertension, and the underlying mechanisms of gut microbiome restoration.

Study Design: A multicenter, randomized, open-label, controlled study.

Data quality control and statistical analysis: The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.

Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.

Connect with a study center

  • Beijing Pinggu Hospital

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

  • First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Second Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong
    China

    Site Not Available

  • First Affiliated Hospital of Jinan University

    Guangzhou 1809858, Guangdong 1809935
    China

    Site Not Available

  • Second Affiliated Hospital of Shantou University Medical College

    Shantou 1795940, Guangdong 1809935
    China

    Site Not Available

  • Longgang District People's Hospital of Shenzhen

    Shenzhen 1795565, Guangdong 1809935
    China

    Site Not Available

  • First affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Site Not Available

  • the Second Affiliated Hospitalof NanChang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • First Affiliated Hospital, Xian Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • Clinical Medical College&Affiliated Hospital of Chengdu University

    Chengdu, Sichuan
    China

    Site Not Available

  • Clinical Medical College&Affiliated Hospital of Chengdu University

    Chengdu 1815286, Sichuan 1794299
    China

    Site Not Available

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing 1816670,
    China

    Site Not Available

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Site Not Available

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906,
    China

    Site Not Available

  • the People's Hospital of Ji Xian District

    Tianjin 1792947,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.