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

Not Applicable

Completed

• Conditions: Hypertension; Prehypertension
• Interventions: Dietary Supplement: Plant-based; Dietary Supplement: High fat dairy

• Registration Number: NCT02397902
• Lead Sponsor: University of Texas at Austin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-25
• Status Verified: 2018-01
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Plant-based	Plant-based	Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks
Dairy	High fat dairy	Add 4 daily servings of high fat dairy to diet for a period of 4 weeks

Primary Outcome Measures

Name	Time	Method
Seated blood pressure	4 weeks

Secondary Outcome Measures

Name	Time	Method
24-hour ambulatory blood pressure	4 weeks
Flow mediated dilation	4 weeks
Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound	4 weeks
Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery	4 weeks

Trial Locations

Locations (1)

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States