Clinical trial NCT01674491: Effects of Black Soy Peptide Supplementation on Blood Pressure
Official title: Effects of Black Soy Peptide Supplementation on Blood Pressure and Oxidative Stress:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in Systolic blood pressure at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in Diastolic blood pressure at 8 weeks
timeFrame: 8 weeks
measure: change from baseline in plasma malondialdehyde at 8 weeks
timeFrame: 8 weeks
measure: change from baseline in Urinary 8-epi-prostaglandin F2 at 8 weeks
timeFrame: 8 weeks
measure: change from baseline in Renin at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline in angiotensin-converting enzyme at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomic
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: