NCT00659672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 9, 2011

Status Verified

February 1, 2011

Enrollment Period

5 months

First QC Date

April 14, 2008

Last Update Submit

February 8, 2011

Conditions

High Blood Pressure

Keywords

hypertensionprehypertensionhigh blood pressureblood pressureheart disease

Outcome Measures

Primary Outcomes (1)

  • systolic and diastolic blood pressure

    monthly

Secondary Outcomes (1)

  • Hormones,lipoproteins, and inflammation

    monthly

Interventions

Whey ProteinDIETARY_SUPPLEMENT

40 grams per day Whey Protein

Soy ProteinDIETARY_SUPPLEMENT

40 grams per day soy protein

Control (carbohydrate)DIETARY_SUPPLEMENT

40 grams per day maltodextrin

Eligibility Criteria

Age28 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Conditions

HypertensionPrehypertensionHeart Diseases

Interventions

Whey ProteinsSoybean ProteinsCarbohydrates

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant ProteinsPlant Proteins, DietarySoy FoodsVegetable ProductsVegetables

Study Officials

  • David J Baer, Ph.D.

    USDA-ARS, Beltsville Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 9, 2011

Record last verified: 2011-02

Locations

US(1)