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Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Soybean peptides
Placebo
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring soybean peptides, clinical trial, blood preesure, SBP, DBP

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Eligible subjects were untreated hypertensive men or women aged between 20 and 80 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;
  • Allergic to Soybean peptides.

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Soybean peptides

Placebo

Arm Description

Subjects receive two bags soybean peptides per day for 8 weeks of a stage.

Subjects receive two bags starch placebo of similar appearance per day for 8 weeks of a stage.

Outcomes

Primary Outcome Measures

The soy bean peptides anti-hypertensive measure blood pressure (SBP and DBP)
values chang of systolbbic and diastolic BPs between before to after 8 weeks

Secondary Outcome Measures

Full Information

First Posted
February 1, 2019
Last Updated
May 20, 2021
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03828955
Brief Title
Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans
Official Title
Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect by Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is the report to assess supplementation with soybean peptides on blood pressure among people with mild hypertension. Overall, soybean peptide consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of Angiotensin-converting enzyme (ACE) linked to downstream suppression of angiotensin II formation, which further decreases the sympathetic outflow that leads to hypertension.
Detailed Description
This is the report to assess supplementation with soybean peptides on blood pressure among people with mild hypertension. Thirty 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 bags of soybean peptides or placebo per day 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
soybean peptides, clinical trial, blood preesure, SBP, DBP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soybean peptides
Arm Type
Experimental
Arm Description
Subjects receive two bags soybean peptides per day for 8 weeks of a stage.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive two bags starch placebo of similar appearance per day for 8 weeks of a stage.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soybean peptides
Intervention Description
Subjects receive two bags soybean peptides 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects receive two bags of starch 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 Measure Information:
Title
The soy bean peptides anti-hypertensive measure blood pressure (SBP and DBP)
Description
values chang of systolbbic and diastolic BPs between before to after 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible subjects were untreated hypertensive men or women aged between 20 and 80 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; Allergic to Soybean peptides.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You-Cheng Mr Shen, Ph.D.
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15853374
Citation
Lo WM, Li-Chan EC. Angiotensin I converting enzyme inhibitory peptides from in vitro pepsin-pancreatin digestion of soy protein. J Agric Food Chem. 2005 May 4;53(9):3369-76. doi: 10.1021/jf048174d.
Results Reference
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PubMed Identifier
18627167
Citation
Rizzello CG, Cassone A, Di Cagno R, Gobbetti M. Synthesis of angiotensin I-converting enzyme (ACE)-inhibitory peptides and gamma-aminobutyric acid (GABA) during sourdough fermentation by selected lactic acid bacteria. J Agric Food Chem. 2008 Aug 27;56(16):6936-43. doi: 10.1021/jf800512u. Epub 2008 Jul 16.
Results Reference
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PubMed Identifier
12677092
Citation
Yoshiji H, Kuriyama S, Fukui H. Angiotensin-I-converting enzyme inhibitors may be an alternative anti-angiogenic strategy in the treatment of liver fibrosis and hepatocellular carcinoma. Possible role of vascular endothelial growth factor. Tumour Biol. 2002 Nov-Dec;23(6):348-56. doi: 10.1159/000069792.
Results Reference
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Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect in Humans

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