Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Low-fat dairy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control foods<br>3 servings per day of control foods | Other: Low-fat dairy<br>* Dietary Intervention of 3 servings per day of low-fat dairy<br>|
| Experimental: Low-fat dairy<br>3 servings per day of low-fat dairy products | Other: Low-fat dairy<br>* Dietary Intervention of 3 servings per day of low-fat dairy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Subjects will be fasted overnight and endothelial function will be determined using the EndoPAT System according to the manufacturer's instructions. The measurements will occur in the index fingers of both hands, simultaneously and will be taken with subjects in a sitting position while in a quiet, thermo- neutral room. | 5 weeks |