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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Hypertension
Hypercholesterolemia
Interventions Dietary Supplement: Soy protein-milk protein-carbohydrate
Dietary Supplement: Milk protein-carbohydrate-soy protein
Dietary Supplement: Carbohydrate-soy protein-milk protein
Enrollment 352
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Soy Protein-milk Protein-carbohydrate Milk Protein-carbohydrate-soy Protein Carbohydrate-soy Protein-milk Protein
Hide Arm/Group 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.
Period Title: Intervention 1 (8 Weeks)
Started 117 117 118
Completed 101 104 101
Not Completed 16 13 17
Period Title: Intervention 2 (8 Weeks)
Started 101 104 101
Completed 93 92 88
Not Completed 8 12 13
Period Title: Intervention 3 (8 Weeks)
Started 93 92 88
Completed 93 92 88
Not Completed 0 0 0
Arm/Group Title Soy Protein-milk Protein-carbohydrate Milk Protein-carbohydrate-soy Protein Carbohydrate-soy Protein-milk Protein Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 117 117 118 352
Hide Baseline Analysis Population Description
Participants randomized to this three-phase cross-over trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants 117 participants 118 participants 352 participants
48.4  (11.5) 46.7  (10.7) 48.1  (8.7) 47.7  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 118 participants 352 participants
Female
48
  41.0%
49
  41.9%
50
  42.4%
147
  41.8%
Male
69
  59.0%
68
  58.1%
68
  57.6%
205
  58.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 117 participants 118 participants 352 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
39
  33.3%
38
  32.5%
44
  37.3%
121
  34.4%
White
78
  66.7%
79
  67.5%
74
  62.7%
231
  65.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 117 participants 117 participants 118 participants 352 participants
117 117 118 352
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 117 participants 117 participants 118 participants 352 participants
127.2  (9.3) 126.7  (11.0) 126.1  (9.7) 126.7  (10.0)
1.Primary Outcome
Title Change From Baseline in Average Systolic Blood Pressure at 8 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
We conducted analysis according to intention-to-treat principle. All participants with data were included in analysis.
Arm/Group Title Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Hide Arm/Group Description:
Cross-over analysis of soy protein supplementation
Cross-over analysis of milk protein supplementation
Cross-over analysis of milk protein supplementation
Overall Number of Participants Analyzed 284 286 287
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-1.5
(-2.4 to -0.6)
-1.8
(-2.7 to -1.0)
0.5
(-0.4 to 1.3)
2.Secondary Outcome
Title Change From Baseline in Serum LDL-cholesterol at 8 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with lipid data
Arm/Group Title Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Hide Arm/Group Description:
Cross-over analysis of soy protein supplementation
Cross-over analysis of milk protein supplementation
Cross-over analysis of milk protein supplementation
Overall Number of Participants Analyzed 284 286 287
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-3.97
(-7.63 to -0.31)
-2.56
(-5.40 to 0.28)
-1.41
(-4.24 to 1.42)
3.Secondary Outcome
Title Body Weight at 8 Weeks
Hide Description Body weight was measured by trained staff using a standard protocol at week 8.
Time Frame Baseline and 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with body weight measures at each intervention phase
Arm/Group Title Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Hide Arm/Group Description:
Cross-over analysis of soy protein supplementation
Cross-over analysis of milk protein supplementation
Cross-over analysis of milk protein supplementation
Overall Number of Participants Analyzed 284 286 287
Mean (95% Confidence Interval)
Unit of Measure: kg
86.2
(84.4 to 88.0)
86.6
(84.9 to 88.4)
86.7
(84.9 to 88.5)
Time Frame Through study completion, an average of 24 weeks
Adverse Event Reporting Description This is a three-phase cross-over trial: 284 participants completed soy protein supplementation, 286 completed milk protein supplementation, and 287 completed carbohydrate supplementation.
 
Arm/Group Title Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Hide Arm/Group Description Cross-over analysis of soy protein supplementation Cross-over analysis of milk protein supplementation Cross-over analysis of milk protein supplementation
All-Cause Mortality
Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/352 (0.00%)   0/352 (0.00%)   0/352 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/352 (0.00%)   0/352 (0.00%)   0/352 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Soy Protein Supplementation Milk Protein Supplementation Carbohydrate Supplementation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/352 (0.00%)   0/352 (0.00%)   0/352 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jiang He, MD, PhD, Chair of Epidemiology
Organization: Tulane University
Phone: 504-988-5165
EMail: jhe@tulane.edu
Layout table for additonal information
Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT00107744     History of Changes
Other Study ID Numbers: H0330
R01HL068057 ( U.S. NIH Grant/Contract )
First Submitted: April 7, 2005
First Posted: April 8, 2005
Results First Submitted: November 30, 2016
Results First Posted: July 4, 2018
Last Update Posted: July 4, 2018