Text Size

Clinical Trial of Protein and Blood Pressure

This study has been completed.
Sponsor:
Information provided by:
Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00107744
First received: April 7, 2005
Last updated: June 23, 2005
Last verified: April 2005
History of Changes
  Purpose

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 Intervention Phase
Hypertension
Hypercholesterolemia
 Behavioral: Dietary protein
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Clinical Trial of Protein and Blood Pressure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • Blood pressure

Secondary Outcome Measures:
  • Lipids

Estimated Enrollment: 300
Study Start Date: January 2000
Estimated Study Completion Date: January 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Tulane University Health Sciences Center

Additional 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
Study First Received: April 7, 2005
Last Updated: June 23, 2005
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertension
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013