Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention

NCT04403347 | Completed

• 1 other identifier: 2017-GZ10 (Part II)
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Microbiome; Treatment; Diet

Outcome Measures

Primary Outcomes (1)

• Change for Office Systolic Blood Pressure (SBP)

  Change for Office Systolic Blood Pressure (SBP)

  From Baseline to the Month 2 (Week 8) follow-up visit

Secondary Outcomes (13)

• Change for office SBP

  Baseline, Month 1(Week 4), Month 3(Week 12)

• Change for Office Diastolic Blood Pressure (DBP)

  Baseline, Month 1(Week 4), Month 2 (Week 8), Month 3 (Week 12)

• Change for daytime average SBP via 24-hour Ambulatory BP Monitoring

  Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)

• Change for daytime average DBP via 24-hour Ambulatory BP Monitoring

  Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)

• Change for nighttime average SBP via 24-hour Ambulatory BP Monitoring

  Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12)

Study Arms (2)

Innovative Dietary Formulation

EXPERIMENTAL

In addition to adherence to a regular diet and usual hypertension care, participants will receive an innovative dietary formulation (TBW diet) incorporated into their daily meals and administered orally.

Dietary Supplement: Innovative Dietary Formulation (Patent ID: CN110250417A)

Usual Care

OTHER

Usual Care (Guideline-based patient education and lifestyle recommendations)

Other: Regular Diet

Interventions

Regular Diet OTHER

Regular Diet with Usual Care

Usual Care

Innovative Dietary Formulation (Patent ID: CN110250417A) DIETARY_SUPPLEMENT

In addition to adherence to a regular diet and standard hypertension care, participants will receive an innovative dietary formulation incorporated into their daily meals and administered orally.

Innovative Dietary Formulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Antibiotics or probiotics usage within last 4 weeks
• Participants of other clinical trials related to hypertension currently or within last 3 months
• Antihypertensive medications usage currently or within last month
• Diagnosed secondary hypertension
• 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 \[\>221 μmol/L\])
• 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.
• Participants preparing for or under pregnancy and/or lactation.
• Other conditions inappropriate for recruitment according to the investigators.

Sponsors & Collaborators

• National Natural Science Foundation of China: collaborator
• Beijing Anzhen Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (8)

Beijing Pinggu Hospital

Beijing, Beijing Municipality, China

Location

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Location

Clinical Medical College&Affiliated Hospital of Chengdu University

Chengdu, Sichuan, China

Location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

the People's Hospital of Ji Xian District

Tianjin, China

Location

Related Publications (3)

• 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 BACKGROUND

• 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.

  PMID: 29590046 BACKGROUND

• 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.

  PMID: 27927713 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Diet

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jun Cai, MD,PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 27, 2020
• Study Start: July 8, 2021
• Primary Completion: August 14, 2024
• Study Completion: September 12, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (8)