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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Soybean peptides; Dietary Supplement: Placebo

• Registration Number: NCT03828955
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-10
• Study Completion: 2017-01
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soybean peptides	Soybean peptides	Subjects receive two bags soybean peptides per day for 8 weeks of a stage.
Placebo	Placebo	Subjects receive two bags starch placebo of similar appearance per day for 8 weeks of a stage.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan