Back to resultsHypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Primary Purpose
Prehypertension, Stage-1 Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-fat dairy
Add 4 servings fruit
Sponsored by
About this trial
This is an interventional treatment trial for Prehypertension
Eligibility Criteria
Inclusion Criteria:
- Prehypertension or stage-1 hypertension
Exclusion Criteria:
- Consume > 3 servings of dairy or fruit per day
- Strenuous physical activity > 3 time per week
- Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
- Taking cardiovascular-acting drugs
- Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease
Sites / Locations
- The University of Texas at Austin, Cardiovascular Aging Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dairy
Fruit
Arm Description
Add 4 daily servings of non-fat dairy to diet for a period of 4 weeks
Add 4 daily servings of fruit to diet, remove all dairy from diet for a period of 4 weeks
Outcomes
Primary Outcome Measures
Seated blood pressure
Secondary Outcome Measures
24-hour ambulatory blood pressure
Carotid arterial compliance
Arterial stiffness
Flow mediated dilation
Full Information
NCT ID
NCT01577030
First Posted
April 10, 2012
Last Updated
February 10, 2014
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT01577030
Brief Title
Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Official Title
Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Elevated systolic blood pressure is by far the largest single contributor to cardiovascular risks in middle-aged and older adults. Lifestyle modifications, including dietary modifications, are the first line approach for treating and preventing hypertension. The general aim of the proposed study is to address the efficacy of conventional dairy products as part of the normal routine diet for lowing arterial blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that the dietary intervention including dairy products will induce significant decreases in arterial blood pressure in this population. A secondary aim will be to test the hypothesis that these reductions in systolic blood pressure will be associated with increases in arterial stiffness/compliance and endothelial vasodilatory function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Stage-1 Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dairy
Arm Type
Experimental
Arm Description
Add 4 daily servings of non-fat dairy to diet for a period of 4 weeks
Arm Title
Fruit
Arm Type
Active Comparator
Arm Description
Add 4 daily servings of fruit to diet, remove all dairy from diet for a period of 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Non-fat dairy
Intervention Description
Add 4 daily servings per day of non-fat dairy (yogurt, milk, cheese) for a period of 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Add 4 servings fruit
Intervention Description
Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and remove all dairy for a period for 4 weeks
Primary Outcome Measure Information:
Title
Seated blood pressure
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
24-hour ambulatory blood pressure
Time Frame
4 weeks
Title
Carotid arterial compliance
Time Frame
4 weeks
Title
Arterial stiffness
Time Frame
4 weeks
Title
Flow mediated dilation
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prehypertension or stage-1 hypertension
Exclusion Criteria:
Consume > 3 servings of dairy or fruit per day
Strenuous physical activity > 3 time per week
Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
Taking cardiovascular-acting drugs
Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirofumi Tanaka, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin, Cardiovascular Aging Research Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25770758
Citation
Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Effects of non-fat dairy products added to the routine diet on vascular function: a randomized controlled crossover trial. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):364-9. doi: 10.1016/j.numecd.2015.01.005. Epub 2015 Jan 31.
Results Reference
derived
PubMed Identifier
24808486
Citation
Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Hypotensive effects of solitary addition of conventional nonfat dairy products to the routine diet: a randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):80-7. doi: 10.3945/ajcn.114.085761. Epub 2014 May 7.
Results Reference
derived
Learn more about this trial
Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
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