NCT00107744

Clinical Trial of Protein and Blood Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The purpose of this randomized, double-blind, controlled trial is to examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension.

Detailed description

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: 350 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.

Conditions

• Hypertension
• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soy protein-milk protein-carbohydrate	40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks
DIETARY_SUPPLEMENT	Milk protein-carbohydrate-soy protein	40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.
DIETARY_SUPPLEMENT	Carbohydrate-soy protein-milk protein	40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks.

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-04-08
• Last updated: 2023-04-12
• Results posted: 2018-07-05