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

Dairy Research Institute

Status

Unknown

Conditions

Hypertension

Treatments

Other: Low-fat dairy

Study type

Interventional

Funder types

Other

Identifiers

NCT01463085

PRV-11022

Details and patient eligibility

About

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.

Enrollment

65 estimated patients

Sex

All

Ages

20 to 69 years old

Volunteers

No Healthy Volunteers

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).