Status:
UNKNOWN
Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
Lead Sponsor:
Dairy Research Institute
Collaborating Sponsors:
BioFortis
Provident Clinical Research
Conditions:
Hypertension
Eligibility:
All Genders
20-69 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.
Eligibility Criteria
Inclusion
- Subject is a female or male, 20-69 years of age, inclusive.
- Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
- Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
- Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
- Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
- Subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.
Exclusion
- Subject has known coronary heart disease (CHD) or a CHD risk equivalent
- Subject has a history of any major trauma or major surgical event
- Subject has digital deformities that would prevent EndoPAT measurements.
- Subject has used medications known to alter body weight
- Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low carbohydrate).
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01463085
Start Date
August 1 2011
End Date
August 1 2012
Last Update
May 24 2012
Active Locations (1)
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1
Biofortis - Provident Clinical Research
Glen Ellyn, Illinois, United States, 60137