Effect of Gut Microbiome Restoration on Primary Hypertension Via Dietary Intervention

Hypertension Clinical Trial

Official title: Effect of Innovative Natural Dietary Formulation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: Pilot Study

Status Recruiting

Clinical Trial 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), 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

• NCT number: NCT04403347
• Study type: Interventional
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: LUYUN FAN, MD
• Phone: 01088392165
• Email: fuwai_fanluyun@163.com
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 8, 2021
• Completion date: September 30, 2023