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Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

This study is currently recruiting participants.
Verified April 2012 by University of Texas at Austin
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01577030
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Prehypertension
Stage-1 Hypertension
 Dietary Supplement: Non-fat dairy
Dietary Supplement: Add 4 servings fruit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Seated blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24-hour ambulatory blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Carotid arterial compliance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Arterial stiffness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Flow mediated dilation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577030

Contacts
Contact: Daniel Machin, MS 512-471-8594 Daniel.r.machin@gmail.com

Locations
United States, Texas
The University of Texas at Austin, Cardiovascular Aging Research Laboratory Recruiting
Austin, Texas, United States, 78712
Contact: Daniel Machin, MS     512-471-8594     Daniel.r.machin@gmail.com    
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Hirofumi Tanaka, PhD University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01577030     History of Changes
Other Study ID Numbers: LH002
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013