Status:
COMPLETED
Clinical Trial of Protein and Blood Pressure
Lead Sponsor:
Tulane University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Hypercholesterolemia
Eligibility:
All Genders
22+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Systolic BP of 120 to 159 mm Hg and diastolic BP of 80 to 95 mm Hg (average of 6 measurements at 2 screening visits)
- Willing to participate in all aspects of the study
Exclusion
- Consumption of dietary protein greater than or equal to 1.63 grams/kg per day, as determined by two 24-hour dietary recalls
- Stage-2 or higher severe hypertension (systolic BP greater than or equal to 160 mm Hg and/or diastolic BP greater than or equal to 95 mm Hg)
- Use of antihypertensive medications or medications that affect BP
- History of clinical heart disease (e.g., angina/heart attack, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
- Kidney disease (serum creatinine level greater than or equal to 1.7 mg/dL for men and greater than or equal to 1.5 mg/dL for women)
- Current hypercholesterolemia (fasting serum total cholesterol greater than or equal to 240 mg/dL) or use of cholesterol-lowering medications
- Current diabetes (fasting serum glucose greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
- Severe obesity (body mass index greater than or equal to 40 kg/m²)
- Current use of prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss greater than 15 pounds within the 6 months prior to study entry
- Cancer (except non-melanoma skin cancer) that required treatment during the year prior to study entry
- Consumption of more than 14 alcoholic beverages per week
- Current participation in another medical study
- Consumption of milk or soy protein greater than or equal to the 90th percentile of intake in the U.S. general population
- Has another member of the household participating in the study
- Study employees or living with study employees
- Allergy or intolerance to soy protein or milk protein products
- Allergy to aspartame
- Plans to move out of the study area (greater than or equal to 50 miles from the study site) and has difficulty coming to the study site
- Inability or unwillingness to cooperate during the screening visits
- Poor compliance during the screening period (intake of less than 85% of supplements)
- Pregnant or plans to become pregnant during the study
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00107744
Start Date
September 1 2003
End Date
April 1 2008
Last Update
April 12 2023
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