The Study of Gut Microbiota in Hypertensive Patients

• Conditions: Gut Microbiota; Hypertension; Diet

• Registration Number: NCT05057039
• Lead Sponsor: Taipei Medical University

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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference of gut microbiota composition between the two groups	immediately after the enrollment completes	The differential OTUs (operational taxonomic units) between the two groups

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan