Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
This trial is active, not recruiting.
|Sponsor||Dairy Research Institute|
|Start date||August 2011|
|End date||August 2012|
|Trial size||65 participants|
|Trial identifier||NCT01463085, PRV-11022|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator)|
Systolic blood pressure
time frame: 5 weeks
time frame: 5 weeks
Male or female participants from 20 years up to 69 years old.
- 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.
- 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).
|Official title||A Randomized, Controlled, Trial to Assess the Effects of Low-fat Dairy Intake on Endothelial Function and Blood Pressure in Subjects With Pre-hypertension or Stage 1 Hypertension|
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