Clinical Trial of Protein and Blood Pressure

Study Overview
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Brief Summary
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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
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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: 350 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.

Official Title
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Clinical Trial of Protein and Blood Pressure

Conditions
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Hypertension, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Soy protein-milk protein-carbohydrate
* Dietary Supplement: Milk protein-carbohydrate-soy protein
* Dietary Supplement: Carbohydrate-soy protein-milk protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The trial participants were assigned to take 40 g/d soy protein, milk protein, or carbohydrate supplementation each for 8 weeks in a random order. A 3-week washout period was implemented between the interventions.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soy protein-milk protein-carbohydrate<br>Participants received 40 grams of soy protein daily for 8 weeks, 40 grams of milk protein daily for 8 weeks, and 40 grams of carbohydrate daily for 8 weeks. | Dietary Supplement: Soy protein-milk protein-carbohydrate<br>* 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks, and 40 grams of carbohydrate per day for 8 weeks<br>|
| Active Comparator: Milk protein-carbohydrate-soy protein<br>Participants received 40 grams of milk protein daily for 8 weeks, 40 grams of carbohydrate daily for 8 weeks, and 40 grams of soy protein daily for 8 weeks. | Dietary Supplement: Milk protein-carbohydrate-soy protein<br>* 40 grams of milk protein per day for 8 weeks, 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks.<br>|
| Active Comparator: Carbohydrate-soy protein-milk protein<br>Participants received 40 grams of complex carbohydrate daily for 8 weeks, 40 grams of soy protein daily for 8 weeks, and 40 grams of milk protein daily for 8 weeks. | Dietary Supplement: Carbohydrate-soy protein-milk protein<br>* 40 grams of carbohydrate per day for 8 weeks, 40 grams of soy protein per day for 8 weeks, 40 grams of milk protein per day for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Systolic Blood Pressure at 8 Weeks | The change of systolic blood pressure was calculated as the mean of 6 blood pressure values from two 8-week visits minus the mean of 6 values from 2 baseline visits within each intervention phase. At each visit, 3 BP values were measured with a Hawksley random-zero sphygmomanometer by trained and certified observers who were masked to group assignment. BP readings were taken from the right arm with appropriately sized cuffs after the participant had been seated quietly for 5 minutes. The participant was instructed not to eat, smoke, drink alcohol, or exercise for at least 30 minutes before their BP measurements. | Baseline and 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum LDL-cholesterol at 8 Weeks | Change in serum LDL-cholesterol was calculated as LDL-cholesterol at 8 weeks minus LDL-cholesterol at baseline. Over-night fasting serum LDL-cholesterol was measured with an enzymatic method. | Baseline and 8 Weeks | 
| Body Weight at 8 Weeks | Body weight was measured by trained staff using a standard protocol at week 8. | Baseline and 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure; Lipids; Dietary Protein