Back to resultsClinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat dairy
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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).
Sites / Locations
- Biofortis - Provident Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control foods
Low-fat dairy
Arm Description
3 servings per day of control foods
3 servings per day of low-fat dairy products
Outcomes
Primary Outcome Measures
Systolic blood pressure
Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01463085
First Posted
October 27, 2011
Last Updated
May 23, 2012
Sponsor
Dairy Research Institute
Collaborators
BioFortis, Provident Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT01463085
Brief Title
Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dairy Research Institute
Collaborators
BioFortis, Provident Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control foods
Arm Type
Placebo Comparator
Arm Description
3 servings per day of control foods
Arm Title
Low-fat dairy
Arm Type
Experimental
Arm Description
3 servings per day of low-fat dairy products
Intervention Type
Other
Intervention Name(s)
Low-fat dairy
Intervention Description
Dietary Intervention of 3 servings per day of low-fat dairy
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Vascular function
Description
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.
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C Maki, PhD
Organizational Affiliation
Biofortis - Provident Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Biofortis - Provident Clinical Research
City
Glen Ellyn
State/Province
Illinois
ZIP/Postal Code
60137
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
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