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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: Low-fat dairy

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Glen Ellyn, Illinois, United States, 60137
      • Biofortis - Provident Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dairy Research Institute
• Collaborators: BioFortis; Provident Clinical Research
• Investigators: Study Director: Kevin C Maki, PhD, Biofortis - Provident Clinical Research

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): May 24, 2012
• Last Update Submitted That Met QC Criteria: May 23, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PRV-11022