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

NCT ID: NCT02397902

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dairy

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

Group Type: EXPERIMENTAL

High fat dairy

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: ACTIVE_COMPARATOR

Plant-based

Intervention Type: 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

Interventions

High fat dairy

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dairy Management Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Roy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tanaka Hirofumi, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Stephen J Roy, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

UTexasAustin

Identifier Type: -

Identifier Source: org_study_id