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Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663127
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
You-Cheng Shen, Chung Shan Medical University

Brief Summary:
This is the report to assess 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 that is linked to downstream suppresion of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: Beauty Drink Dietary Supplement: Placebo Not Applicable

Detailed Description:
This is the report to assess 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 "Beauty Drink" or placebo perday for 8 weeks of a stage. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial
Actual Study Start Date : July 26, 2018
Actual Primary Completion Date : December 21, 2018
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Beauty Drink
Subjects receive two bottles "Beauty Drink" per day for 8 weeks of a stage.
Dietary Supplement: Beauty Drink
Subjects receive two bottles "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, hipline and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every four weeks.

Placebo Comparator: Placebo
Subjects receive two bottles placebo per day for 8 weeks of a stage.
Dietary Supplement: Placebo
Subjects receive two bottles placebo of similar appearance 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, hipline and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every four weeks.




Primary Outcome Measures :
  1. The changes of blood pressure of the subjects (SBP and DBP) [ Time Frame: 8 weeks ]
    values chang of systolbbic and diastolic BPs between before to after 8 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663127


Locations
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Taiwan
Chung Shan Medical University
Taichung, Taiwan
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: You-Cheng Mr Shen, Ph.D. Chung Shan Medical University
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Responsible Party: You-Cheng Shen, School of Health Diet and Industry Managment, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03663127    
Other Study ID Numbers: CS18077
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by You-Cheng Shen, Chung Shan Medical University:
gamma-aminobutyric acid
blood pressure
clinical trial
angiotensin converting enzyme
Beauty Drink
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases