NCT01577030

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

April 10, 2012

Last Update Submit

February 10, 2014

Conditions

PrehypertensionStage-1 Hypertension

Outcome Measures

Primary Outcomes (1)

  • Seated blood pressure

    4 weeks

Secondary Outcomes (4)

  • 24-hour ambulatory blood pressure

    4 weeks

  • Carotid arterial compliance

    4 weeks

  • Arterial stiffness

    4 weeks

  • Flow mediated dilation

    4 weeks

Study Arms (2)

Dairy

EXPERIMENTAL

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

Dietary Supplement: Non-fat dairy

Fruit

ACTIVE COMPARATOR

Add 4 daily servings of fruit to diet, remove all dairy from diet for a period of 4 weeks

Dietary Supplement: Add 4 servings fruit

Interventions

Non-fat dairyDIETARY_SUPPLEMENT

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

Dairy
Add 4 servings fruitDIETARY_SUPPLEMENT

Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and remove all dairy for a period for 4 weeks

Fruit

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin, Cardiovascular Aging Research Laboratory

Austin, Texas, 78712, United States

Location

Related Publications (2)

  • Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Effects of non-fat dairy products added to the routine diet on vascular function: a randomized controlled crossover trial. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):364-9. doi: 10.1016/j.numecd.2015.01.005. Epub 2015 Jan 31.

    PMID: 25770758DERIVED

  • Machin DR, Park W, Alkatan M, Mouton M, Tanaka H. Hypotensive effects of solitary addition of conventional nonfat dairy products to the routine diet: a randomized controlled trial. Am J Clin Nutr. 2014 Jul;100(1):80-7. doi: 10.3945/ajcn.114.085761. Epub 2014 May 7.

    PMID: 24808486DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hirofumi Tanaka, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 13, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

US(1)