NCT03973710

Brief Summary

Dysbiosis of gut microbiota has been reported to be involved in the development and progression of hypertension in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate hypertension in adults remain obscure.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

June 3, 2019

Last Update Submit

May 3, 2022

Conditions

Hypertension

Keywords

ProbioticsPreventionHypertension

Outcome Measures

Primary Outcomes (3)

  • changes of systolic blood pressure

    changes of systolic blood pressure

    baseline, 4 weeks, 8 weeks and 12 weeks

  • changes of diastolic blood pressure

    changes of diastolic blood pressure

    baseline, 4 weeks, 8 weeks and 12 weeks

  • changes of gut microbiota

    changes of gut microbiota by metagenomics

    baseline, 4 weeks, 8 weeks and 12 weeks

Secondary Outcomes (3)

  • changes of pulse wave velocity

    baseline and after 12-week intervention

  • changes of ankle brachial index

    baseline and after 12-week intervention

  • changes of microbial metabolite

    baseline and after 12-week intervention

Study Arms (2)

Probiotics group

EXPERIMENTAL

Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Dietary Supplement: Lactobacillus paracasei dietary supplement

Placebo group

PLACEBO COMPARATOR

Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Dietary Supplement: Placebo controls

Interventions

Lactobacillus paracasei dietary supplementDIETARY_SUPPLEMENT

a commercial probiotic dietary supplement

Probiotics group
Placebo controlsDIETARY_SUPPLEMENT

placebo with a similar appearance to probiotics supplement

Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible subjects include men and women 18 to 75 years of age with pre-hypertension who has a systemic blood between 120 and 139 mmHg and/ or a diastolic blood pressure between 80 and 80 mmHg;
  • Absence of any diet, dietary supplement and medications that might interfere with blood pressure and gut microbiota, especially antibiotics and probiotics.

You may not qualify if:

  • Any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
  • Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
  • Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
  • Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;
  • Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Min Xia, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 4, 2019

Study Start

June 3, 2022

Primary Completion

March 31, 2023

Study Completion

December 31, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)