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Effect of Whey Protein on Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659672
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : February 9, 2011
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center

Tracking Information
First Submitted Date  ICMJE April 14, 2008
First Posted Date  ICMJE April 16, 2008
Last Update Posted Date February 9, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)		 systolic and diastolic blood pressure [ Time Frame: monthly ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2008)		 Hormones,lipoproteins, and inflammation [ Time Frame: monthly ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Whey Protein on Blood Pressure
Official Title  ICMJE Effect of Whey Protein on Blood Pressure
Brief Summary The purpose of this study is to determine if consumption of whey protein, compared with soy protein or a carbohydrate food decreases blood pressure along with reducing risk factors for heart disease.
Detailed Description

Several lines of evidence suggest that consumption of dairy foods, and specifically whey protein, may reduce blood pressure. This proposed study is designed investigate the effect of whey protein compared to another protein source.

Since blood pressure is a recognized risk factor for cardiovascular disease, if there is clear evidence that whey protein reduces blood pressure, dietary recommendations may be made regarding whey protein intake. However, dietary recommendations to consume whey protein as a means to improve health status must be science-based. Results from this study will provide a scientific basis for dietary recommendations regarding whey protein intake.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE High Blood Pressure
Intervention  ICMJE
  • Dietary Supplement: Whey Protein
    40 grams per day Whey Protein
  • Dietary Supplement: Soy Protein
    40 grams per day soy protein
  • Dietary Supplement: Control (carbohydrate)
    40 grams per day maltodextrin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: April 15, 2008)		 35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI between 25 and 42 kg/m2
  • Fasting glucose < 126 mg/dl
  • Blood pressure > 120/80 and < 160/100 mm Hg [based two measurements collected on separate days]

Exclusion Criteria:

  • Use of prescription or over-the-counter medications that alter blood pressure.
  • Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
  • Women who have given birth during the previous 12 months.
  • Pregnant women or women who plan to become pregnant or become pregnant during the study.
  • Lactating women.
  • Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
  • Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
  • Volunteers who have lost 10% of body weight within the last 12 months.
  • Use of vitamin and mineral supplements or antacids containing magnesium or calcium.
  • Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
  • Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
  • Smokers or other tobacco users (during the 6 months prior to the start of the study).
  • Known (self-reported) allergy or adverse reaction to dairy products (including lactose) or soy.
  • Unable or unwilling to give informed consent or communicate with study staff.
  • Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Years to 70 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00659672
Other Study ID Numbers  ICMJE 2007-384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party David J. Baer, Ph.D, Principal Investigator, USDA-ARS
Original Responsible Party Same as current
Current Study Sponsor  ICMJE United States Department of Agriculture (USDA)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David J Baer, Ph.D. USDA-ARS, Beltsville Human Nutrition Research Center
PRS Account USDA Beltsville Human Nutrition Research Center
Verification Date February 2011

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