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Clinical Trial of Protein and Blood Pressure (ProBP)

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ClinicalTrials.gov Identifier: NCT00107744
Recruitment Status : Completed
First Posted : April 8, 2005
Results First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tulane University

Tracking Information
First Submitted Date  ICMJE April 7, 2005
First Posted Date  ICMJE April 8, 2005
Results First Submitted Date  ICMJE November 30, 2016
Results First Posted Date  ICMJE July 4, 2018
Last Update Posted Date July 4, 2018
Study Start Date  ICMJE September 2003
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
Change From Baseline in Average Systolic Blood Pressure at 8 Weeks [ Time Frame: Baseline and 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Blood pressure
Change History Complete list of historical versions of study NCT00107744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • Change From Baseline in Serum LDL-cholesterol at 8 Weeks [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 8 Weeks ]
    Body weight was measured by trained staff using a standard protocol at week 8.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Lipids
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Protein and Blood Pressure
Official Title  ICMJE Clinical Trial of Protein and Blood Pressure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator, Outcomes 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.
Primary Purpose: Prevention
Condition  ICMJE
  • Hypertension
  • Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Soy protein-milk protein-carbohydrate
    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
  • Dietary Supplement: Milk protein-carbohydrate-soy protein
    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.
  • Dietary Supplement: Carbohydrate-soy protein-milk protein
    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.
Study Arms  ICMJE
  • Active Comparator: Soy protein-milk protein-carbohydrate
    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.
    Intervention: Dietary Supplement: Soy protein-milk protein-carbohydrate
  • Active Comparator: Milk protein-carbohydrate-soy protein
    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.
    Intervention: Dietary Supplement: Milk protein-carbohydrate-soy protein
  • Active Comparator: Carbohydrate-soy protein-milk protein
    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: Dietary Supplement: Carbohydrate-soy protein-milk protein
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2018)
352
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
300
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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)
  2. Willing to participate in all aspects of the study

Exclusion Criteria:

  1. Consumption of dietary protein greater than or equal to 1.63 grams/kg per day, as determined by two 24-hour dietary recalls
  2. 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)
  3. Use of antihypertensive medications or medications that affect BP
  4. History of clinical heart disease (e.g., angina/heart attack, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
  5. 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)
  6. Current hypercholesterolemia (fasting serum total cholesterol greater than or equal to 240 mg/dL) or use of cholesterol-lowering medications
  7. Current diabetes (fasting serum glucose greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
  8. Severe obesity (body mass index greater than or equal to 40 kg/m²)
  9. 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
  10. Cancer (except non-melanoma skin cancer) that required treatment during the year prior to study entry
  11. Consumption of more than 14 alcoholic beverages per week
  12. Current participation in another medical study
  13. Consumption of milk or soy protein greater than or equal to the 90th percentile of intake in the U.S. general population
  14. Has another member of the household participating in the study
  15. Study employees or living with study employees
  16. Allergy or intolerance to soy protein or milk protein products
  17. Allergy to aspartame
  18. 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
  19. Inability or unwillingness to cooperate during the screening visits
  20. Poor compliance during the screening period (intake of less than 85% of supplements)
  21. Pregnant or plans to become pregnant during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00107744
Other Study ID Numbers  ICMJE H0330
R01HL068057 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tulane University
Study Sponsor  ICMJE Tulane University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: Jiang He, MD, PhD Tulane University
PRS Account Tulane University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP