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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397902
• Other study ID #: UTexasAustin
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: January 30, 2018
• Start date: March 2015
• Est. completion date: January 30, 2018

Study information

• Verified date: January 2018
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 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

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

Dietary Supplement:
• High fat dairy
Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks
• Plant-based
Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Dairy Management Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seated blood pressure		4 weeks
Secondary	24-hour ambulatory blood pressure		4 weeks
Secondary	Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound		4 weeks
Secondary	Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery		4 weeks
Secondary	Flow mediated dilation		4 weeks