Clinical trial NCT03828955: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: soybean peptides
clinical trial
blood preesure
SBP
DBP
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The soy bean peptides anti-hypertensive measure blood pressure (SBP and DBP)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: You-Cheng Mr Shen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.