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

Evaluation of Soybean Peptides Product on Regulation of Blood Pressure Effect by Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Soybean peptides; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Soybean peptides; Subjects receive two bags soybean peptides per day for 8 weeks of a stage.	Dietary supplement: Soybean peptides; 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.
PLACEBO_COMPARATOR: Placebo; Subjects receive two bags starch placebo of similar appearance per day for 8 weeks of a stage.	Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (ACTUAL): February 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: clinical trial; SBP; DBP; soybean peptides; blood preesure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CS15123