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Effects of Black Soy Peptide Supplementation on Blood Pressure

NCT ID: NCT01674491

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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4.5g/day black soy peptide

4.5 g/day, 8weeks

Group Type EXPERIMENTAL

black soy peptide

Intervention Type DIETARY_SUPPLEMENT

black soy peptide: 4.5g/day for 8 weeks

placebo

similar appearance to the black soy peptide tablet, 8 weeks

Group Type PLACEBO_COMPARATOR

black soy peptide

Intervention Type DIETARY_SUPPLEMENT

black soy peptide: 4.5g/day for 8 weeks

Interventions

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black soy peptide

black soy peptide: 4.5g/day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong Ho Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Laboratory of Clinical Nutrigenetics/Nutrigenomic

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BPS_201106

Identifier Type: -

Identifier Source: org_study_id