Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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 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.

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

2026-05

Completion Date

2027-05

Last Updated

2026-05-11

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Bifidobacterium probiotics supplementation

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.

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong