Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

Prehypertension Clinical Trial

Official title:

Hypotensive Effects of Conventional Dairy Products: Role of Arterial Stiffness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577030
• Other study ID #: LH002
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: February 10, 2014
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prehypertension
• Stage-1 Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas at Austin, Cardiovascular Aging Research Laboratory	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seated blood pressure		4 weeks	No
Secondary	24-hour ambulatory blood pressure		4 weeks	No
Secondary	Carotid arterial compliance		4 weeks	No
Secondary	Arterial stiffness		4 weeks	No
Secondary	Flow mediated dilation		4 weeks	No