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NCT05057039 Clinical Trial

The Study of Gut Microbiota in Hypertensive Patients

Hypertension Clinical Trial

Official title:
The Study of Gut Microbiota in Hypertensive Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05057039
Other study ID # CGH-P110063
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2023

Study information
Verified date January 2023
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

The investigators plan to enroll total 70 hypertensive and normotensive cases from the elderly health examination in Cathay General Hospital, who are aged from 65 to 80 years. Body mass index and blood samples for biochemical analysis such as blood sugar and cholesterol levels are taken, and fecal samples are collected for analysis of gut microbiota, which is characterized by 16S ribosomal RNA gene sequencing. Besides, the diet and nutrients intake are recorded and calculated by licensed dietitian. Through the exploration of gut microbiota in hypertensive patients, the results can be the reference for clinical treatment.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 70
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria: 1. Age 65~80 years old 2. People who join the Elderly Health Examination Program in Cathay General Hospital in 2021 Exclusion Criteria: 1. Antibiotics use within one month 2. Acute gastrointestinal illness within one week, such as vomiting and diarrhea 3. History of gastrointestinal surgery 4. History of inflammatory bowel disease 5. Chronic gastrointestinal disease under medication treatment 6. Cannot finish dietary record

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Taipei Medical University Taipei

Sponsors (2)
Lead Sponsor Collaborator
Taipei Medical University Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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