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
Other: Low-fat dairy
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Locations near you
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Full eligibility criteria for NCT01463085
Ages eligible for Study
20 Years to 69 Years
Genders eligible for Study
Accepts Healthy Volunteers
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).
All locations for NCT01463085
United States (1)
Biofortis - Provident Clinical Research
Glen Ellyn, Illinois, United States, 60137
View full eligibility
Tris trial is registered with FDA with number: NCT01463085. The sponsor of the trial is Dairy Research Institute and it is looking for 65 volunteers for the current phase.
Official trial 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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