Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
NCT ID: NCT01463085
Last Updated: 2012-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
65 participants
INTERVENTIONAL
2011-08-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Control foods
3 servings per day of control foods
Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy
Low-fat dairy
3 servings per day of low-fat dairy products
Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy
Interventions
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Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
20 Years
69 Years
ALL
No
Sponsors
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BioFortis
OTHER
Provident Clinical Research
OTHER
Dairy Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kevin C Maki, PhD
Role: STUDY_DIRECTOR
Biofortis - Provident Clinical Research
Locations
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Biofortis - Provident Clinical Research
Glen Ellyn, Illinois, United States
Countries
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Other Identifiers
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PRV-11022
Identifier Type: -
Identifier Source: org_study_id
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