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Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

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ClinicalTrials.gov Identifier: NCT01577030
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Prehypertension Stage-1 Hypertension Dietary Supplement: Non-fat dairy Dietary Supplement: Add 4 servings fruit

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness
Study Start Date : January 2012
Primary Completion Date : October 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Seated blood pressure [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577030


Locations
United States, Texas
The University of Texas at Austin, Cardiovascular Aging Research Laboratory
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Hirofumi Tanaka, PhD University of Texas at Austin