Hypertension
Conditions
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.
Interventions
DIETARY_SUPPLEMENTblack soy peptide
black soy peptide: 4.5g/day for 8 weeks
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in Systolic blood pressure at 8 weeks | 8 weeks |
Secondary
| 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 |
Countries
South Korea
Outcome results
None listed