Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
| Beijing Anzhen Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | Other | Usual Care (Guideline-based patient education and lifestyle recommendations) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change for office SBP | Change for office SBP | Baseline, Month 1(Week 4), Month 3(Week 12) |
| Change for Office Diastolic Blood Pressure (DBP) | Change for Office Diastolic Blood Pressure (DBP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jun Cai, MD,PhD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Pinggu Hospital | Beijing | Beijing Municipality | China | |||
| First Affiliated Hospital of Jinan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28143587 | Background | 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. | |
| 29590046 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Regular Diet | Other | Regular Diet with Usual Care |
|
| 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 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 | 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 | 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 DBP 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) |
| Number of Participants with Adverse Events (AEs) as a Measure of Safety | Number of Participants with Adverse Events (AEs) as a Measure of Safety | All AEs over 3 months |
| Intestinal Microbiota Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis | 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 function Pre- and Post-intervention (innovative dietary formulation or usual care) via Metagenomic Analysis | 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) |
| Plasma Metabolite Composition Pre- and Post-intervention (innovative dietary formulation or usual care) via Metabolomic 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) |
| Change for Fasting Blood Glucose Level | Change for Fasting Blood Glucose Level | Baseline, Month 2(Week 8) |
| Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol) | Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol) | Baseline, Month 2(Week 8) |
| Change for Body Mass Index | Change for Body Mass Index | Baseline, Month 2(Week 8) |
| Guangzhou |
| Guangdong |
| China |
| Second Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | China |
| Longgang District People's Hospital of Shenzhen | Shenzhen | Guangdong | China |
| Clinical Medical College&Affiliated Hospital of Chengdu University | Chengdu | Sichuan | China |
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |
| First Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| the People's Hospital of Ji Xian District | Tianjin | China |
| 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. |
| 27927713 | 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. |