Effects of Black Soy Peptide Supplementation on Blood Pressure

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: black soy peptide

• Registration Number: NCT01674491
• Lead Sponsor: Yonsei University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-27
• Last Update Submitted: 2012-08-27
• Study First Posted: 2012-08-28
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4.5g/day black soy peptide	black soy peptide	4.5 g/day, 8weeks
placebo	black soy peptide	similar appearance to the black soy peptide tablet, 8 weeks

Primary Outcome Measures

Name	Time	Method
change from baseline in Systolic blood pressure at 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomic; 🇰🇷 Seoul, Korea, Republic of