NCT03828955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

February 1, 2019

Last Update Submit

May 20, 2021

Conditions

Hypertension

Keywords

soybean peptidesclinical trialblood preesureSBPDBP

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Soybean peptides

EXPERIMENTAL

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

Dietary Supplement: Soybean peptides

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Soybean peptidesDIETARY_SUPPLEMENT

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.

Soybean peptides
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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;
  • Allergic to Soybean peptides.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 15853374BACKGROUND

  • 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.

    PMID: 18627167BACKGROUND

  • 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.

    PMID: 12677092BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular 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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Health Diet and Industry Managment

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 4, 2019

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

May 24, 2021

Record last verified: 2021-05

Locations

TW(1)