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

Tracking Information
First Received Date ^ICMJE	April 7, 2005
Last Updated Date	June 23, 2005
Start Date ^ICMJE	January 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Blood pressure
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00107744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Lipids
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Clinical Trial of Protein and Blood Pressure
Official Title ^ICMJE	Clinical Trial of Protein and Blood Pressure
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.
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 ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Hypertension Hypercholesterolemia
Intervention ^ICMJE	Behavioral: Dietary protein
Study Arm (s)
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	January 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00107744
Other Study ID Numbers ^ICMJE	No Id
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Tulane University Health Sciences Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Tulane University Health Sciences Center
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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