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Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products

Primary Purpose

Hypertension, Prehypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High fat dairy
Plant-based
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dairy

Plant-based

Arm Description

Add 4 daily servings of high fat dairy to diet for a period of 4 weeks

Add 4 daily servings of fruit to diet and/or plant-based milk, 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 as measured by arterial pressure and corresponding cross-sectional area by ultrasound
Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery
Flow mediated dilation

Full Information

First Posted
March 16, 2015
Last Updated
January 30, 2018
Sponsor
University of Texas at Austin
Collaborators
Dairy Management Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02397902
Brief Title
Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
Official Title
Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Dairy Management Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. The investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. If our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Prehypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dairy
Arm Type
Experimental
Arm Description
Add 4 daily servings of high fat dairy to diet for a period of 4 weeks
Arm Title
Plant-based
Arm Type
Active Comparator
Arm Description
Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
High fat dairy
Intervention Description
Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant-based
Intervention Description
Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, 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 as measured by arterial pressure and corresponding cross-sectional area by ultrasound
Time Frame
4 weeks
Title
Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery
Time Frame
4 weeks
Title
Flow mediated dilation
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 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
Tanaka Hirofumi, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen J Roy, MS
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

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Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products

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