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:

MedlinePlus related topics: Dietary Proteins

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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1161/CIRCULATIONAHA.110.009159. Epub 2011 Jul 18.


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 Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on September 27, 2016

To Top