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

NCT02397902 | Completed DMC

• 1 other identifier: UTexasAustin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Prehypertension

Outcome Measures

Primary Outcomes (1)

• Seated blood pressure

  4 weeks

Secondary Outcomes (4)

• 24-hour ambulatory blood pressure

  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

• Flow mediated dilation

  4 weeks

Study Arms (2)

Dairy

EXPERIMENTAL

Add 4 daily servings of high fat dairy to diet for a period of 4 weeks

Dietary Supplement: High fat dairy

Plant-based

ACTIVE COMPARATOR

Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks

Dietary Supplement: Plant-based

Interventions

High fat dairy DIETARY_SUPPLEMENT

Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks

Dairy

Plant-based DIETARY_SUPPLEMENT

Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks

Plant-based

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prehypertension or stage-1 hypertension

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Dairy Management Inc.: collaborator

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tanaka Hirofumi, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Stephen J Roy, MS

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (1)