Clinical Trial of Protein and Blood Pressure
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Clinical Trial of Protein and Blood Pressure|
- Blood pressure
|Study Start Date:||January 2000|
|Estimated Study Completion Date:||January 2004|
Background: Epidemiologic studies suggest that vegetable protein intake is inversely related to blood pressure.
Objectives: To examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension
Design: Randomized, double-blind, controlled trial
Study Participants: 300 participants, aged 35-64 years, with an initial untreated systolic blood pressure of 130-159 mmHg and/or diastolic blood pressure of 80-99 mmHg
Intervention: Study participants will be randomly assigned to take 40-grams of isolated soybean protein supplements per day or complex carbohydrate control for 12 weeks.
Outcomes: Blood pressure measurements will be obtained using random-zero sphygmomanometers at baseline and during the trial at weeks 6 and 12. Net changes in systolic and diastolic blood pressure before and after the intervention is the primary outcome.