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NOT YET RECRUITING
NCT07206303
PHASE1

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

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 10 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.

Official title: The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension: a Single-term Feasibility Pilot Study

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-12

Completion Date

2026-12

Last Updated

2025-11-19

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Bifidobacterium probiotics supplementation

The 10-week research period consists of one prescreening and baseline visit (week -1) and two follow-up visits (week 5 (±7days) and week 10 (±7days)). The participants will be instructed to fast overnight before their visits in the mornings of week -1 and week 10. 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 5 and 10. 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 10 weeks. They will be instructed to mix the probiotics with water and consume with their dinner.

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong