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

January 30, 2018 updated by: Stephen J. Roy, University of Texas at Austin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dairy
Add 4 daily servings of high fat dairy to diet for a period of 4 weeks
Dietary supplement: High fat dairy
Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks
Active Comparator: Plant-based
Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks
Dietary supplement: Plant-based
Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seated blood pressure
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
24-hour ambulatory blood pressure
Time Frame: 4 weeks
4 weeks
Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound
Time Frame: 4 weeks
4 weeks
Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery
Time Frame: 4 weeks
4 weeks
Flow mediated dilation
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Dairy Management Inc.

Investigators

  • Principal Investigator: Tanaka Hirofumi, PhD, The University of Texas at Austin
  • Principal Investigator: Stephen J Roy, MS, The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTexasAustin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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