The primary objective of this study is to investigate if a Bifidobacterium-based probiotic intervention would reduce clinic systolic BP in untreated middle-aged Chinese men and women with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) after 12 weeks of treatment. The investigators anticipate that this feasibility study will provide rationale to conduct a larger randomized clinical trial and preliminary data to estimate the power/ sample size of a larger RCT.
Men or women, aged 40-65 years old.
Chinese residing in Hong Kong.
Clinic SBP ≥130mmHg according to screening measurement at baseline.
Untreated or not on antihypertensive medications within 4 weeks.
Clinic SBP >165mmHg according to screening measurement at baseline
Known history of diabetes, coronary artery disease, stroke, peripheral artery disease, malignancy or chronic kidney disease
Known history of gastrointestinal disorders including inflammatory bowel disease, irritable bowel syndrome, Helicobacter pylori infection, liver cirrhosis or long-term use of proton pump inhibitors.
Known increased risk of infection due to endovascular or rheumatic heart disease, endovascular grafts, congenital heart defects, endocarditis, mechanical heart valves, and permanent endovascular devices including permanent (not temporary) hemodialysis catheters, pacemakers, or defibrillators.
Single group
Bifidobacterium probiotics supplementation
Biological/VaccineThe 12-week research period consists of one prescreening and baseline visit (week -1) and three follow-up visits (week 4 (±7days), week 8 (±7days) and week 12 (±7days)). The participants will be instructed to fast overnight before their visits in the mornings of week -1 and week 12. The measurements will include documentation of personal and demographic information; three consecutive clinic BP readings; 24-hour ambulatory BP monitoring; a 3-day diet diary to monitor consistency of dietary intake; collection of fecal samples and blood samples for analysis of GM composition and biomarkers, respectively at baseline, and week 8 and 12. Only participants who are able to provide all the required data and samples within 7 days after the prescreening and baseline visit (week -1) will be eligible to receive the Bifidobacterium supplementation with 20 billion cfu once a day for 12 weeks. They will be instructed to mix the probiotics with water and consume with their dinner.
Mean seated clinic systolic blood pressure (SBP)
Three consecutive BP measurements will be assessed using an automatic BP monitor, Microlife BP A200 AFIB (Microlife, Taiwan). Prior to taking BP measurements, participants will be instructed to sit and rest for at least five minutes. Participants will be advised to maintain an upright posture, with their arms positioned at heart level and palms facing upwards. Additionally, they will be advised to refrain from speaking during process. The average of three BP measurements will be taken to minimize random error.
Mean seated clinic diastolic blood pressure (DBP)
Three consecutive BP measurements will be assessed using an automatic BP monitor, Microlife BP A200 AFIB (Microlife, Taiwan). Prior to taking BP measurements, participants will be instructed to sit and rest for at least five minutes. Participants will be advised to maintain an upright posture, with their arms positioned at heart level and palms facing upwards. Additionally, they will be advised to refrain from speaking during process. The average of three BP measurements will be taken to minimize random error.
Mean 24-hour ambulatory SBP
A calibrated ambulatory BP monitoring device, TM-2441 (A\&D Medical, Japan) will be fitted onto the participants, with the BP cuff placed on their non-dominant arm to record the 24-hour ambulatory BP. The BP will be measured every 30 minutes from 6 am to 10 pm and then every 60 minutes from 10 pm to 6 am.
Gut microbiome composition and functions
Stool GM sequencing will be performed to compare GM abundance before and after probiotics intervention. This will enable metagenomic assembly community profiling and functional profiling, while facilitating the identification of presented taxa, their abundance, biochemical potential, and other relevant information. Other GM species that may be associated with hypertension could also be identified and provide valuable insights for the development of future GM-based intervention strategies. A set of OMNIgene-OMR205 kits (DNA Genotek, Canada) will be utilized for the collection and stabilization of gut microbial DNA and RNA, facilitating the profiling of gut microbiomes. We will also inquire about the participants' bowel habit concurrently, utilizing the Bristol Stool Chart as reference.
Plasma levels of gut microbiome-derived metabolites, short-chain fatty acids (SCFA) and gamma amino butyric acids (GABA)
The level of SCFAs in blood sample will be detected by a two-steps analysis: the blood sample will be first derivatized by 1-propanol/pyridine (3:2, v: v) and propyl chloroformate followed by the quantification using 7890B gas chromatography-mass spectrometry after centrifugation of blood.
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