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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Hypercholesterolemia | Behavioral: Dietary protein | Phase 3 |
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) |
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 |
Study Completion Date : | January 2004 |

- Blood pressure
- Lipids

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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:
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |