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Clinical Trial of Protein and Blood Pressure

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ClinicalTrials.gov Identifier: NCT00107744
Recruitment Status : Completed
First Posted : April 8, 2005
Last Update Posted : June 24, 2005
Information provided by:
Tulane University Health Sciences Center

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Hypercholesterolemia Behavioral: Dietary protein Phase 3

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: 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)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Clinical Trial of Protein and Blood Pressure
Study Start Date : January 2000
Estimated Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Proteins
U.S. FDA Resources

Primary Outcome Measures :
  1. Blood pressure

Secondary Outcome Measures :
  1. Lipids

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Trial participants were men and women 35 to 65 years of age who had an average systolic blood pressure of 130-159 mmHg and/or diastolic blood pressure of 80-99 mmHg based on an average of 9 readings (3 observations at each of 3 screening visits).

Exclusion Criteria:

  • Self-reported use of antihypertensive medications during the preceding two months
  • History of cardiovascular disease, diabetes mellitus, cancer, chronic obstructive pulmonary disease, psychiatric disease, or any other serious life-threatening illness that required regular medical treatment
  • Serum creatinine ≥150.3 µmol/L (1.7 mg/dL) at the screening examination
  • Alcohol intake ≥21 drinks/week or ≥40 grams/day
  • Women who were currently pregnant or intended to become pregnant during the study were also excluded

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00107744     History of Changes
Other Study ID Numbers: No Id
First Posted: April 8, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2005

Keywords provided by Tulane University Health Sciences Center:
Blood Pressure; Lipids; Dietary Protein

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases