NCT01674491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

August 10, 2012

Last Update Submit

August 27, 2012

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • change from baseline in Systolic blood pressure at 8 weeks

    8 weeks

Secondary Outcomes (5)

  • 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

Study Arms (2)

4.5g/day black soy peptide

EXPERIMENTAL

4.5 g/day, 8weeks

Dietary Supplement: black soy peptide

placebo

PLACEBO COMPARATOR

similar appearance to the black soy peptide tablet, 8 weeks

Dietary Supplement: black soy peptide

Interventions

black soy peptideDIETARY_SUPPLEMENT

black soy peptide: 4.5g/day for 8 weeks

4.5g/day black soy peptideplacebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomic

Seoul, 120-749, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jong Ho Lee, Ph.D

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 28, 2012

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

KR(1)