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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03663127
Other study ID # CS18077
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 26, 2018
Est. completion date June 30, 2019

Study information

Verified date August 2021
Source Chung Shan Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Overall, "Beauty Drink" consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of ACE linked to downstream suppression of angiotensin II formation, which further decreases the sympathetic outflow leads to hypertension.


Description:

This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Fifty subjects with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized to ingest 2 bottles of "Beauty Drink" or placebo per day for 8 weeks of a stage. In addition, anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every four weeks.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 30, 2019
Est. primary completion date December 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Eligible subjects were untreated hypertensive men or women aged between 20 and 70 years old with SBP between 120 and 159 mmHg and/or DBP between 80 and 99 mmHg as measured in a sitting position Exclusion Criteria: - Subjects were excluded if they had a history of major cardiovascular disease or severe liver dysfunction; Diastolic blood pressure = 100 mmHg or Systolic blood pressure = 160 mmHg; - Alcoholic; - US-controlled diabetics; - Stoke in past one year; - Mental diseases or melancholia; - Pregnancy or breast-feeding a child; - Renal dysfunction;

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Beauty Drink
Subjects receive two bottles of "Beauty Drink" per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.
Placebo
Subjects receive two bottles of placebo of similar appearance per day for 8 weeks of a stage. In addition, anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.

Locations

Country Name City State
Taiwan Chung Shan Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The changes of blood pressure of the subjects (SBP and DBP) values change of systolic and diastolic BPs between before to after 8 weeks 8 weeks
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