This trial is active, not recruiting.

Condition hypertension
Treatment low-fat dairy
Sponsor Dairy Research Institute
Collaborator BioFortis
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
3 servings per day of control foods
low-fat dairy
Dietary Intervention of 3 servings per day of 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

Primary Outcomes

Systolic blood pressure
time frame: 5 weeks

Secondary Outcomes

Vascular function
time frame: 5 weeks

Eligibility Criteria

Male or female participants from 20 years up to 69 years old.

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).

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Dairy Research Institute.