<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04403347</url>
  </required_header>
  <id_info>
    <org_study_id>2017-GZ10 (Part II)</org_study_id>
    <nct_id>NCT04403347</nct_id>
  </id_info>
  <brief_title>Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention</brief_title>
  <official_title>Effect of Innovative Natural Dietary Formulation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mounting preclinical and clinical evidences have proved the optimal role of diets (i.e. DASH&#xD;
      (Dietary Approaches to Stop Hypertension) diet, Mediterranean diet) on BP control and a&#xD;
      causal role of gut microbiota on the pathogenesis of primary hypertension. Dietary changes&#xD;
      appeared to reshape gut microbiota and to ameliorate diseases such as Type 2 Diabetes. A&#xD;
      hypothesis is thus raised that dietary changes can be a potential approach to ameliorate&#xD;
      hypertension via gut microbiome restoration. This pilot study will utilize an innovative&#xD;
      natural dietary formulation (patent ID: CN110250417A), in comparison with classic&#xD;
      antihypertensive treatment (losartan 50mg per day) and usual care (guideline-based patient&#xD;
      education and lifestyle recommendations), to investigate its effect and safety on primary&#xD;
      hypertension treatment, and the underlying mechanisms of gut microbiome restoration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global&#xD;
      public health issue because of the high morbidity and potential risk to other cardiovascular&#xD;
      diseases. Several animal studies and diverse patient cohorts reported that the disorder of&#xD;
      gut microbiome correlated with hypertension. Based on the investigators' previous work&#xD;
      findings of metagenomics analysis, fecal transplantation and metabolomics changes in&#xD;
      hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was&#xD;
      observed in primary hypertension and raised a hypothesis that gut microbiome restoration can&#xD;
      be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics,&#xD;
      probiotics, dietary changes and other methodologies can assist gut microbiome restoration in&#xD;
      diseases such as type 2 diabetes. The investigators therefore develop two pilot studies&#xD;
      respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot&#xD;
      Study II) to explore the methodologies, effect, safety and underlying mechanisms of gut&#xD;
      microbiome restoration on hypertension. These pilot studies also present as the clinical&#xD;
      translational part of the research project &quot;The Role of Gut Microbiome in the Pathogenesis of&#xD;
      Essential Hypertension&quot;(Project ID 81630014, sponsored by National Natural Science Foundation&#xD;
      of China).&#xD;
&#xD;
      This study is the Pilot Study II:&#xD;
&#xD;
      Objective: With reference of DASH diet and Mediterranean diet, this study aims to explore the&#xD;
      effect and safety of an innovative natural dietary formulation on primary hypertension, and&#xD;
      the underlying mechanisms of gut microbiome restoration.&#xD;
&#xD;
      Study Design: A multicenter, randomized, open-label, positive- and negative- controlled,&#xD;
      pilot study.&#xD;
&#xD;
      Data quality control and statistical analysis: The investigators have invited professional&#xD;
      statistic analysts to assist analyzing data and a third party to supervise data quality.&#xD;
&#xD;
      Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before&#xD;
      patient enrollment are required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change for Office Systolic Blood Pressure (SBP)</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Change for Office Systolic Blood Pressure (SBP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change for Office Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Change for Office Diastolic Blood Pressure (DBP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for daytime average SBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Change for daytime average SBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for daytime average DBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Change for daytime average DBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Month 1, Month 2, Month 3</time_frame>
    <description>Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events (AEs) as a Measure of Safety</measure>
    <time_frame>All AEs over 3 months</time_frame>
    <description>Number of Participants with Adverse Events (AEs) as a Measure of Safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis</measure>
    <time_frame>Baseline, Month 1，Month 2，Month 3</time_frame>
    <description>Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis</measure>
    <time_frame>Baseline, Month 1，Month 2，Month 3</time_frame>
    <description>Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intestinal and Serum Metabolite Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metabolomic Analysis</measure>
    <time_frame>Baseline, Month 1，Month 2，Month 3</time_frame>
    <description>Intestinal and Serum Metabolite Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metabolomic Analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Fasting Blood Glucose Level</measure>
    <time_frame>Baseline, Month 2</time_frame>
    <description>Change for Fasting Blood Glucose Level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)</measure>
    <time_frame>Baseline, Month 2</time_frame>
    <description>Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Body Mass Index</measure>
    <time_frame>Baseline, Month 2</time_frame>
    <description>Change for Body Mass Index</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Innovative Dietary Formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to regular diets and usual care of hypertension, additional innovative dietary formulation will be orally taken 3 times per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antihypertensive Medication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to regular diets and usual care of hypertension, antihypertensive medication will be orally taken (Losartan 50mg per day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care (Guideline-based patient education and lifestyle recommendations)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Innovative Dietary Formulation (Patent ID: CN110250417A)</intervention_name>
    <description>In addition to regular diets and usual care of hypertension, additional innovative natural dietary formulation derived from tartary buckwheat will be orally taken 3 times per day.</description>
    <arm_group_label>Innovative Dietary Formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan 50mg per day</intervention_name>
    <description>In addition to regular diets and usual care of hypertension, antihypertensive medication will be orally taken (Losartan 50mg per day).</description>
    <arm_group_label>Antihypertensive Medication</arm_group_label>
    <other_name>Antihypertensive Medication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18~60 years.&#xD;
&#xD;
          2. Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from&#xD;
             antihypertensive drugs within a month): 140mmHg≤ Office SBP&lt;160mmHg for three&#xD;
             measurements at different days without any antihypertensive medications, according to&#xD;
             the &quot;2010 Chinese Guidelines for Prevention and Treatment of Hypertension&quot;.&#xD;
&#xD;
          3. Patients with informed consent after thorough explanation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Antibiotics or probiotics usage within last 4 weeks&#xD;
&#xD;
          2. Participants of other clinical trials related to hypertension currently or within last&#xD;
             3 months&#xD;
&#xD;
          3. Antihypertensive medications usage currently or within last month&#xD;
&#xD;
          4. Diagnosed secondary hypertension&#xD;
&#xD;
          5. Severe hepatic or renal diseases ((ALT &gt;3 times the upper limit of normal value, or&#xD;
             end stage renal disease on dialysis or eGFR &lt;30 mL/min/1.73 m2, or serum creatinine&#xD;
             &gt;2.5 mg/dl [&gt;221 μmol/L])&#xD;
&#xD;
          6. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not&#xD;
             including lacunar infarction and transient ischemic attack [TIA])&#xD;
&#xD;
          7. Hospitalization for myocardial infarction within last 6 months; Coronary&#xD;
             revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the&#xD;
             next 12 months.&#xD;
&#xD;
          8. Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic&#xD;
             BP measurement.&#xD;
&#xD;
          9. NYHA class III-IV heart failure; Hospitalization for chronic heart failure&#xD;
             exacerbation within last 6 months.&#xD;
&#xD;
         10. Severe valvular diseases; Potential for surgery or percutaneous valve replacement&#xD;
             within the study period.&#xD;
&#xD;
         11. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease;&#xD;
             Congenital heart disease.&#xD;
&#xD;
         12. Other severe diseases influencing the entry or survival of participants, such as&#xD;
             malignant tumor or acquired immune deficiency syndrome.&#xD;
&#xD;
         13. Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of&#xD;
             providing their own informed consent.&#xD;
&#xD;
         14. Participants preparing for or under pregnancy and/or lactation.&#xD;
&#xD;
         15. Other conditions inappropriate for recruitment according to the investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Cai, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>LUYUN FAN, MD</last_name>
    <phone>01088392165</phone>
    <email>fuwai_fanluyun@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>LU WANG</last_name>
    <phone>01088392165</phone>
    <email>wanglu@fuwai.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>First Affiliated Hospital of Jinan University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Guo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Shantou University Medical College</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youren Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Medical College&amp;Affiliated Hospital of Chengdu University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yamei Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qifu Li</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.</citation>
    <PMID>28143587</PMID>
  </reference>
  <reference>
    <citation>Zhao L, Zhang F, Ding X, Wu G, Lam YY, Wang X, Fu H, Xue X, Lu C, Ma J, Yu L, Xu C, Ren Z, Xu Y, Xu S, Shen H, Zhu X, Shi Y, Shen Q, Dong W, Liu R, Ling Y, Zeng Y, Wang X, Zhang Q, Wang J, Wang L, Wu Y, Zeng B, Wei H, Zhang M, Peng Y, Zhang C. Gut bacteria selectively promoted by dietary fibers alleviate type 2 diabetes. Science. 2018 Mar 9;359(6380):1151-1156. doi: 10.1126/science.aao5774.</citation>
    <PMID>29590046</PMID>
  </reference>
  <reference>
    <citation>Marques FZ, Nelson E, Chu PY, Horlock D, Fiedler A, Ziemann M, Tan JK, Kuruppu S, Rajapakse NW, El-Osta A, Mackay CR, Kaye DM. High-Fiber Diet and Acetate Supplementation Change the Gut Microbiota and Prevent the Development of Hypertension and Heart Failure in Hypertensive Mice. Circulation. 2017 Mar 7;135(10):964-977. doi: 10.1161/CIRCULATIONAHA.116.024545. Epub 2016 Dec 7.</citation>
    <PMID>27927713</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Jun Cai</investigator_full_name>
    <investigator_title>Director，Hypertension Center</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Treatment</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Losartan</mesh_term>
    <mesh_term>Antihypertensive Agents</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403347
org study id: 2017-GZ10 (Part II)
nct id: NCT04403347
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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), in comparison with classic
      antihypertensive treatment (losartan 50mg per day) and 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.
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 on primary hypertension, and
      the underlying mechanisms of gut microbiome restoration.

      Study Design: A multicenter, randomized, open-label, positive- and negative- controlled,
      pilot 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change for Office Systolic Blood Pressure (SBP)
time frame: Baseline, Month 1, Month 2, Month 3
description: Change for Office Systolic Blood Pressure (SBP)
measure: Change for Office Diastolic Blood Pressure (DBP)
time frame: Baseline, Month 1, Month 2, Month 3
description: Change for Office Diastolic Blood Pressure (DBP)
measure: Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Month 1, Month 2, Month 3
description: Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
measure: Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Month 1, Month 2, Month 3
description: Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
measure: Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Month 1, Month 2, Month 3
description: Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring
measure: Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Month 1, Month 2, Month 3
description: Change for nighttime average DBP via 24-hour Ambulatory BP Monitoring
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety
time frame: All AEs over 3 months
description: Number of Participants with Adverse Events (AEs) as a Measure of Safety
measure: Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis
time frame: Baseline, Month 1，Month 2，Month 3
description: Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis
measure: Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis
time frame: Baseline, Month 1，Month 2，Month 3
description: Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metagenomic Analysis
measure: Intestinal and Serum Metabolite Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metabolomic Analysis
time frame: Baseline, Month 1，Month 2，Month 3
description: Intestinal and Serum Metabolite Composition Pre- and Post-intervention (innovative dietary formulation, losartan 50mg per day, or usual care) via Metabolomic Analysis
measure: Change for Fasting Blood Glucose Level
time frame: Baseline, Month 2
description: Change for Fasting Blood Glucose Level
measure: Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
time frame: Baseline, Month 2
description: Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
measure: Change for Body Mass Index
time frame: Baseline, Month 2
description: Change for Body Mass Index
arm group label: Innovative Dietary Formulation
arm group type: Experimental
description: In addition to regular diets and usual care of hypertension, additional innovative dietary formulation will be orally taken 3 times per day.
arm group label: Antihypertensive Medication
arm group type: Active Comparator
description: In addition to regular diets and usual care of hypertension, antihypertensive medication will be orally taken (Losartan 50mg per day).
arm group label: Usual Care
arm group type: No Intervention
description: Usual Care (Guideline-based patient education and lifestyle recommendations)
intervention type: Dietary Supplement
intervention name: Innovative Dietary Formulation (Patent ID: CN110250417A)
description: In addition to regular diets and usual care of hypertension, additional innovative natural dietary formulation derived from tartary buckwheat will be orally taken 3 times per day.
arm group label: Innovative Dietary Formulation
intervention type: Drug
intervention name: Losartan 50mg per day
description: In addition to regular diets and usual care of hypertension, antihypertensive medication will be orally taken (Losartan 50mg per day).
arm group label: Antihypertensive Medication
other name: Antihypertensive Medication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jun Cai, MD,PhD
role: Principal Investigator
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
last name: LUYUN FAN, MD
phone: 01088392165
email: fuwai_fanluyun@163.com
last name: LU WANG
phone: 01088392165
email: wanglu@fuwai.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
PMID: 28143587
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responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Jun Cai
investigator title: Director，Hypertension Center
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Losartan
mesh term: Antihypertensive Agents