Effects of Black Soy Peptide Supplementation on Blood Pressure

Effects of Black Soy Peptide Supplementation on Blood Pressure and Oxidative Stress:A Randomized Controlled Trial

Black soy peptides have been shown to possess properties that may decrease blood pressure. To examine the effects of black soy peptides supplementation on blood pressure and oxidative stress in subjects with pre-hypertension or stage I hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: black soy peptide

Detailed Description

Trial participants included men and women aged 30 to 65 years who had an average systolic blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits. Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3 pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received pouches containing casein that had a similar appearance to the black soy peptide tablet. During the intervention, we instructed study participants to continue their current food intake patterns and lifestyles so that total energy intake and energy expenditure would be constant during the course of trial. Participants brought back unconsumed pouches at their 4- and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we used this to assess the participants' adherence to their assigned intervention.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-749
    • Laboratory of clinical Nutrigenetics/Nutrigenomic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Average systolic blood pressure (SBP) between 130 to 159 mmHg
• Average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits

Exclusion Criteria:

• Previous diagnosed clinical hypertension
• Self-reported use of anti-hypertensive medication
• Abnormal liver or renal function
• History of cardiovascular disease, cancer, thyroid or pituitary disease, or any other serious life-threatening illness that required regular medical treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4.5g/day black soy peptide; 4.5 g/day, 8weeks	Dietary supplement: black soy peptide; black soy peptide: 4.5g/day for 8 weeks
Placebo Comparator: placebo; similar appearance to the black soy peptide tablet, 8 weeks	Dietary supplement: black soy peptide; black soy peptide: 4.5g/day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in Systolic blood pressure at 8 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Diastolic blood pressure at 8 weeks	8 weeks
change from baseline in plasma malondialdehyde at 8 weeks	8 weeks
change from baseline in Urinary 8-epi-prostaglandin F2 at 8 weeks	8 weeks
change from baseline in Renin at 8 weeks	8 weeks
Change from baseline in angiotensin-converting enzyme at 8 weeks	8 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Estimate): August 28, 2012
• Last Update Submitted That Met QC Criteria: August 27, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: BPS_201106