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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01463085
Recruitment Status : Unknown
Verified May 2012 by Dairy Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : November 1, 2011
Last Update Posted : May 24, 2012
Provident Clinical Research
Information provided by (Responsible Party):
Dairy Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Low-fat dairy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Arm Intervention/treatment
Placebo Comparator: Control foods
3 servings per day of control foods
Other: Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy
Experimental: Low-fat dairy
3 servings per day of low-fat dairy products
Other: Low-fat dairy
Dietary Intervention of 3 servings per day of low-fat dairy

Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 5 weeks ]
    Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.

Secondary Outcome Measures :
  1. Vascular function [ Time Frame: 5 weeks ]
    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.

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01463085

United States, Illinois
Biofortis - Provident Clinical Research
Glen Ellyn, Illinois, United States, 60137
Sponsors and Collaborators
Dairy Research Institute
Provident Clinical Research
Study Director: Kevin C Maki, PhD Biofortis - Provident Clinical Research

Responsible Party: Dairy Research Institute Identifier: NCT01463085     History of Changes
Other Study ID Numbers: PRV-11022
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases