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

April 7, 2005
June 23, 2005
January 2000
Not Provided
Blood pressure
Same as current
Complete list of historical versions of study NCT00107744 on ClinicalTrials.gov Archive Site
Lipids
Same as current
Not Provided
Not Provided
 
Clinical Trial of Protein and Blood Pressure
Clinical Trial of Protein and Blood Pressure

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Hypertension
  • Hypercholesterolemia
Behavioral: Dietary protein
Not Provided
He J, Wofford MR, Reynolds K, Chen J, Chen CS, Myers L, Minor DL, Elmer PJ, Jones DW, Whelton PK. Effect of dietary protein supplementation on blood pressure: a randomized, controlled trial. Circulation. 2011 Aug 2;124(5):589-95. Epub 2011 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
January 2004
Not Provided

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00107744
No Id
Not Provided
Not Provided
Tulane University Health Sciences Center
Not Provided
Not Provided
Tulane University Health Sciences Center
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP