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

NCT03663127 | Completed DMC

• 1 other identifier: CS18077
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

gamma-aminobutyric acid; blood pressure; clinical trial; angiotensin converting enzyme; Beauty Drink

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Beauty Drink

EXPERIMENTAL

Subjects receive two bottles "Beauty Drink" per day for 8 weeks of a stage.

Dietary Supplement: Beauty Drink

Placebo

PLACEBO COMPARATOR

Subjects receive two bottles placebo per day for 8 weeks of a stage.

Dietary Supplement: Placebo

Interventions

Beauty Drink DIETARY_SUPPLEMENT

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.

Beauty Drink

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• You-Cheng Mr Shen, Ph.D.

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: July 26, 2018
• Primary Completion: December 21, 2018
• Study Completion: June 30, 2019
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

TW (1)