Clinical Trial of Dietary Protein and Blood Pressure

Completed · Not applicable

Conditions studied: Cardiovascular Diseases, Hypertension, Heart Diseases

In brief

The purpose of this study is to examine the effect of dietary protein supplements on high blood pressure (BP).

Key facts

Study ID

NCT00046566

Run by

Tulane University

People needed

352

Starts

2002-07-01

Expected to finish

2008-04-01

Last updated by the study team

2017-07-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tulane University — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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