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CompletedNCT00659672Updated Feb 9, 2011

Effect of Whey Protein on Blood Pressure

An interventional study of Whey Protein and Soy Protein in High Blood Pressure, sponsored by United States Department of Agriculture (USDA). Completed at 1 site in United States. Open to participants aged 28 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-09.

Sponsored by United States Department of Agriculture (USDA) · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
28 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • High Blood Pressure

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Keywords

  • hypertension
  • prehypertension
  • high blood pressure
  • blood pressure
  • heart disease
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 35 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

United States Department of Agriculture (USDA) is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Interventions

  • Dietary supplementWhey Protein

    40 grams per day Whey Protein

  • Dietary supplementSoy Protein

    40 grams per day soy protein

  • Dietary supplementControl (carbohydrate)

    40 grams per day maltodextrin

06

What researchers measure

Primary outcomes

  1. systolic and diastolic blood pressure

    Time frame: monthly

Secondary outcomes

  1. Hormones,lipoproteins, and inflammation

    Time frame: monthly

07

Study locations

1 site
  • USDA Beltsville Human Nutrition Research Center
    Beltsville, Maryland 20705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00659672
Lead sponsor
United States Department of Agriculture (USDA)
First posted
Apr 16, 2008
Start date
Sep 2008
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Feb 9, 2011

Study contacts

David J Baer, Ph.D.
principal investigator · USDA-ARS, Beltsville Human Nutrition Research Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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