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Completed

NCT Number: NCT02397902

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fat dairy

Dietary Supplement

Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks

Plant-based

Dietary Supplement

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 outcomes

  1. Seated blood pressure

    Time frame: 4 weeks

Secondary outcomes

  1. 24-hour ambulatory blood pressure

    Time frame: 4 weeks

  2. Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound

    Time frame: 4 weeks

  3. Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery

    Time frame: 4 weeks

  4. Flow mediated dilation

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Dairy Management Inc.

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2015
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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