NCT05057039

Brief Summary

Recent animal and human studies have found the relationship between the composition of the gut microbiota and hypertension, but some studies did not have a detailed evaluation of the diet content, which could be an important effect on gut microbiota. Moreover, most of these studies were finished in Western countries, in which the dietary patterns were significantly different from those in Chinese regions. This study intends to establish Taiwanese local data to explore the differences in the composition of gut microbiota among hypertensive patients and normotensive subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

September 9, 2021

Last Update Submit

April 14, 2023

Conditions

HypertensionGut MicrobiotaDiet

Outcome Measures

Primary Outcomes (1)

  • The difference of gut microbiota composition between the two groups

    The differential OTUs (operational taxonomic units) between the two groups

    immediately after the enrollment completes

Study Arms (2)

hypertensive group

SBP \>=140mmHg, DBP \>=90mmHg, or use of antihypertensive drug

normotensive group

SBP \<=140mmHg and DBP \<=90mmHg without use of antihypertensive drug

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

People who join the Elderly Health Examination Program in Cathay General Hospital in 2021

You may qualify if:

  • Age 65\~80 years old
  • People who join the Elderly Health Examination Program in Cathay General Hospital in 2021

You may not qualify if:

  • Antibiotics use within one month
  • Acute gastrointestinal illness within one week, such as vomiting and diarrhea
  • History of gastrointestinal surgery
  • History of inflammatory bowel disease
  • Chronic gastrointestinal disease under medication treatment
  • Cannot finish dietary record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 27, 2021

Study Start

September 1, 2021

Primary Completion

August 31, 2023

Study Completion

December 31, 2023

Last Updated

April 18, 2023

Record last verified: 2023-01

Locations

TW(1)