Clinical Trial of Protein and Blood Pressure
|ClinicalTrials.gov Identifier: NCT00107744|
Recruitment Status : Completed
First Posted : April 8, 2005
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Hypercholesterolemia||Behavioral: Dietary protein||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Trial of Protein and Blood Pressure|
|Study Start Date :||January 2000|
|Study Completion Date :||January 2004|
- Blood pressure