Effects of Black Soy Peptide Supplementation on Blood Pressure

Yonsei University

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Dietary Supplement: black soy peptide

Study type: Interventional

Funder types: Other

Identifiers

NCT01674491

BPS_201106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

4.5g/day black soy peptide

Experimental group

Description:

4.5 g/day, 8weeks

Treatment:

Dietary Supplement: black soy peptide

placebo

Placebo Comparator group

Description:

similar appearance to the black soy peptide tablet, 8 weeks

Treatment:

Dietary Supplement: black soy peptide