search
Back to results

Clinical Trial of Protein and Blood Pressure (ProBP)

Primary Purpose

Hypertension, Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soy protein-milk protein-carbohydrate
Milk protein-carbohydrate-soy protein
Carbohydrate-soy protein-milk protein
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Blood Pressure; Lipids; Dietary Protein

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Soy protein-milk protein-carbohydrate

    Milk protein-carbohydrate-soy protein

    Carbohydrate-soy protein-milk protein

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Body Weight at 8 Weeks
    Body weight was measured by trained staff using a standard protocol at week 8.

    Full Information

    First Posted
    April 7, 2005
    Last Updated
    April 10, 2023
    Sponsor
    Tulane University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00107744
    Brief Title
    Clinical Trial of Protein and Blood Pressure
    Acronym
    ProBP
    Official Title
    Clinical Trial of Protein and Blood Pressure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tulane University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Hypercholesterolemia
    Keywords
    Blood Pressure; Lipids; Dietary Protein

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    The randomization assignment list was generated by a computer program that could only be accessed by the study data coordinator. Apart from the data coordinator, all research personnel, including investigators, study coordinators, and BP technicians, and the study participants were unaware of treatment assignment.
    Allocation
    Randomized
    Enrollment
    352 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Soy protein-milk protein-carbohydrate
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Milk protein-carbohydrate-soy protein
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Carbohydrate-soy protein-milk protein
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Soy protein-milk protein-carbohydrate
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Milk protein-carbohydrate-soy protein
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Carbohydrate-soy protein-milk protein
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Average Systolic Blood Pressure at 8 Weeks
    Description
    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.
    Time Frame
    Baseline and 8 Weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Serum LDL-cholesterol at 8 Weeks
    Description
    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.
    Time Frame
    Baseline and 8 Weeks
    Title
    Body Weight at 8 Weeks
    Description
    Body weight was measured by trained staff using a standard protocol at week 8.
    Time Frame
    Baseline and 8 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiang He, MD, PhD
    Organizational Affiliation
    Tulane University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15652604
    Citation
    Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.
    Results Reference
    background
    PubMed Identifier
    21768541
    Citation
    He J, Wofford MR, Reynolds K, Chen J, Chen CS, Myers L, Minor DL, Elmer PJ, Jones DW, Whelton PK. Effect of dietary protein supplementation on blood pressure: a randomized, controlled trial. Circulation. 2011 Aug 2;124(5):589-95. doi: 10.1161/CIRCULATIONAHA.110.009159. Epub 2011 Jul 18.
    Results Reference
    result
    PubMed Identifier
    21952693
    Citation
    Wofford MR, Rebholz CM, Reynolds K, Chen J, Chen CS, Myers L, Xu J, Jones DW, Whelton PK, He J. Effect of soy and milk protein supplementation on serum lipid levels: a randomized controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):419-25. doi: 10.1038/ejcn.2011.168. Epub 2011 Sep 28.
    Results Reference
    result
    PubMed Identifier
    23187956
    Citation
    Rebholz CM, Reynolds K, Wofford MR, Chen J, Kelly TN, Mei H, Whelton PK, He J. Effect of soybean protein on novel cardiovascular disease risk factors: a randomized controlled trial. Eur J Clin Nutr. 2013 Jan;67(1):58-63. doi: 10.1038/ejcn.2012.186. Epub 2012 Nov 28.
    Results Reference
    result

    Learn more about this trial

    Clinical Trial of Protein and Blood Pressure

    We'll reach out to this number within 24 hrs