Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

February 10, 2014 updated by: University of Texas at Austin
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

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, Cardiovascular Aging Research Laboratory

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

35 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 non-fat dairy to diet for a period of 4 weeks
Dietary supplement: Non-fat dairy
Add 4 daily servings per day of non-fat dairy (yogurt, milk, cheese) for a period of 4 weeks
Active Comparator: Fruit
Add 4 daily servings of fruit to diet, remove all dairy from diet for a period of 4 weeks
Dietary supplement: Add 4 servings fruit
Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and 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
Flow mediated dilation
Time Frame: 4 weeks
4 weeks
Carotid arterial compliance
Time Frame: 4 weeks
4 weeks
Arterial stiffness
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LH002

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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