The Study of Gut Microbiota in Hypertensive Patients

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Diet; Gut Microbiota

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
hypertensive group; SBP >=140mmHg, DBP >=90mmHg, or use of antihypertensive drug
normotensive group; SBP <=140mmHg and DBP <=90mmHg without use of antihypertensive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Cathay General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CGH-P110063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No