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OpenTrials
Completed

NCT Number: NCT01577030

Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

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.

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Key information

Conditions

Prehypertension Cardiovascular Diseases Stage-1 Hypertension Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin, Cardiovascular Aging Research Laboratory

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

Non-fat dairy

Dietary Supplement

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

Add 4 servings fruit

Dietary Supplement

Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and 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

    Time frame: 4 weeks

  3. Arterial stiffness

    Time frame: 4 weeks

  4. Flow mediated dilation

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 13, 2012
Registry last updated
Feb 12, 2014

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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