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Clinical Trial of Protein and Blood Pressure
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension Hypercholesterolemia | Behavioral: Dietary protein | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Clinical Trial of Protein and Blood Pressure |
- Blood pressure
- Lipids
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | January 2004 |
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 |
| 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
Contacts and LocationsNo Contacts or Locations Provided
More Information
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 |
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 July 21, 2017