Hypertension
Conditions
Keywords
Hypertension, Microbiome, Treatment, Diet
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTInnovative Dietary Formulation (Patent ID: CN110250417A)
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.
OTHERRegular Diet
Regular Diet with Usual Care
Sponsors
National Natural Science Foundation of China
Beijing Anzhen Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 60 years. 2. 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. 3. Patients with informed consent after thorough explanation.
Exclusion criteria
1. Antibiotics or probiotics usage within last 4 weeks 2. Participants of other clinical trials related to hypertension currently or within last 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, or end stage renal disease on dialysis or eGFR \<30 mL/min/1.73 m2, or serum creatinine \>2.5 mg/dl \[\>221 μmol/L\]) 6. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not including lacunar infarction and transient ischemic attack \[TIA\]) 7. 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. 8. Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic BP measurement. 9. NYHA class III-IV heart failure; Hospitalization for chronic heart failure exacerbation within last 6 months. 10. Severe valvular diseases; Potential for surgery or percutaneous valve replacement within 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 as malignant tumor or acquired immune deficiency syndrome. 13. Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent. 14. Participants preparing for or under pregnancy and/or lactation. 15. Other conditions inappropriate for recruitment according to the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change for Office Systolic Blood Pressure (SBP) | From Baseline to the Month 2 (Week 8) follow-up visit | Change for Office Systolic Blood Pressure (SBP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change for Office Diastolic Blood Pressure (DBP) | Baseline, Month 1(Week 4), Month 2 (Week 8), Month 3 (Week 12) | Change for Office Diastolic Blood Pressure (DBP) |
| 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 SBP via 24-hour Ambulatory BP Monitoring |
| 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 daytime average DBP via 24-hour Ambulatory BP Monitoring |
| Change for nighttime average SBP 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 |
| Change for nighttime 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 DBP via 24-hour Ambulatory BP Monitoring |
| Number of Participants with Adverse Events (AEs) as a Measure of Safety | All AEs over 3 months | Number of Participants with Adverse Events (AEs) as a Measure of Safety |
| Change for office SBP | Baseline, Month 1(Week 4), Month 3(Week 12) | Change for office SBP |
| Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis | Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12) | Intestinal Microbiota function Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis |
| Plasma Metabolite Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metabolomic Analysis | Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12) | Plasma Metabolite Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metabolomic Analysis |
| Change for Fasting Blood Glucose Level | Baseline, Month 2(Week 8) | Change for Fasting Blood Glucose Level |
| Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol) | Baseline, Month 2(Week 8) | Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol) |
| Change for Body Mass Index | Baseline, Month 2(Week 8) | Change for Body Mass Index |
| Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis | Baseline, Month 1(Week 4), Month 2(Week 8), Month 3(Week 12) | Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis |
Countries
China
Outcome results
None listed