The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension

Sponsor
The University of Hong Kong
Study ID
NCT07206303
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bifidobacterium probiotics supplementation — BIOLOGICAL
    The 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.

Study Details

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.

Key Dates

First listed
Oct 3, 2025
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 30 recruited participants receiving commercially available probiotics supplements
    30 community-dwelling, middle-aged Hong Kong Chinese (15 men and 15 women) with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) who are not taking antihypertensive agents and are free of symptomatic cardiovascular or cerebrovascular diseases will be recruited in this study. Participants will be recruited via our outreach promotion program or social media and recruitment posters will be distributed physically or posted online.

Primary Outcome Measure

Mean seated clinic systolic blood pressure (SBP) [ Time Frame: During clinical visits at: - Baseline (a week prior to treatment), - Week 4, 8 of treatment - Week 12 of treatment (end of treatment) ]

Central Contacts

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