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Completed

NCT Number: NCT03828955

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soybean peptides

Dietary 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.

Placebo

Dietary 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.

Primary outcomes

  1. The soy bean peptides anti-hypertensive measure blood pressure (SBP and DBP)

    Time frame: 8 weeks

    values chang of systolbbic and diastolic BPs between before to after 8 weeks

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 4, 2019
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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