Blueberry Consumption Improves Vascular Function and Lowers Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension

NCT01686282 | Completed Phase 2 DMC

• 1 other identifier: 021259
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans have been more concerned about their blood cholesterol levels and dietary cholesterol intakes rather than their overall cardiovascular health risk factors leading to CVD such as hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and physical activity. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to increased arterial stiffness. The investigators long-term goal is to provide feasible and effective dietary ways for pre- and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve vascular function and thereby reducing their cardiovascular risk and enhancing the quality of life. Blueberries are a rich source of phenolic compounds and these compounds may play an important role in promoting cardiovascular health. Considering the strong possibility that phytochemicals present in blueberry work additively or synergistically, it would be ideal to investigate the cardioprotective effects of blueberry as a whole. The investigators overall objective to bring forth evidence that blueberry consumption will reduce BP and cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The investigators hypothesize that blueberry supplementation will improve vascular function and will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this study will provide a foundation for disseminating feasible, safe approaches for preventing and combating hypertension at its early stage which does not require drug therapy.

Conditions

Blood Pressure

Keywords

Blood pressure; Arterial Stiffness; Blueberry Supplementation; Aortic Blood Pressure; Hypertension; Postmenopausal; Pulse Wave Velocity

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  By measuring aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  8 weeks

Secondary Outcomes (6)

• Autonomic Control of Blood Pressure

  8 weeks

• Autonomic Control of Heart Rate

  8 weeks

• Endothelial Function

  8 week

• Inflammation

  8 weeks

• Oxidative Stress

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day.

Dietary Supplement: Placebo

Blueberry

EXPERIMENTAL

8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day.

Dietary Supplement: Freeze-dried Blueberry Powder

Interventions

Freeze-dried Blueberry Powder DIETARY_SUPPLEMENT

8 weeks of freeze-dried taken in two doses of 22g each per day.

Also known as: U.S. Highbush Blueberry Council

Blueberry

Placebo DIETARY_SUPPLEMENT

8 weeks of freeze-dried taken in two doses of 22g each per day.

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women (1 to 10 years after natural menopause or bilateral oophorectomy) 45-65 years of age.
• Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/90 mm Hg.

You may not qualify if:

• Blood pressure \>160/100 mmHg
• Taking insulin
• Cardiovascular disease
• Active cancer
• Asthma
• Glaucoma
• Thyroid disease
• Kidney disease
• Liver disease
• Pancreatic disease
• Enrollment in a weight loss program
• Heavy smokers (\>20 cigarettes per day)

Sponsors & Collaborators

• Florida State University: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

The Department of Nutrition, Food, and Exercise Sciences, Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.

  PMID: 25578927 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bahram H Arjmandi, PhD, RD

  Florida State University

  PRINCIPAL INVESTIGATOR

• Arturo Figueroa, MD, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

• Sarah A Johnson, PhD, RD, CSO

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 18, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)