Clinical trial NCT01686282: Blueberry Consumption Improves Vascular Function and Lowers Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension
Official title: Daily Incorporation of Blueberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blood Pressure
Keywords: Blood pressure
Arterial Stiffness
Blueberry Supplementation
Aortic Blood Pressure
Hypertension
Postmenopausal
Pulse Wave Velocity
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: U.S. Highbush Blueberry Council
First posted: 2012-09-18
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this study is to examine the effects of 22 grams of freeze-dried blueberry intake on a daily basis for eight weeks in:

The purpose of the study is to examine the effects of 22 grams of freeze-dried blueberry intake on a daily basis for eight weeks on arterial function and blood pressure in postmenopausal women with pre- and stage 1-hypertension. The specific aims of the study are:

1. To investigate the extent to which daily consumption of 22 g blueberry drink-mix reduces blood pressure in individuals with pre- and stage 1-hypertension.
2. To determine whether daily consumption of 22 g blueberry drink-mix will improve the autonomic control of blood pressure and heart rate in individuals with pre- and stage 1-hypertension.
3. To measure serum markers of oxidative stress to determine whether increased antioxidant defense is in part responsible for blueberry's vascular protective effects.

Eligibility criteria: Inclusion Criteria:

* 40 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Autonomic Control of Blood Pressure
timeFrame: 8 weeks
measure: Autonomic Control of Heart Rate
timeFrame: 8 weeks
measure: Endothelial Function
timeFrame: 8 week
measure: Inflammation
timeFrame: 8 weeks
measure: Oxidative Stress
timeFrame: 8 weeks
measure: Arterial Stiffness
timeFrame: 8 Week
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: The Department of Nutrition, Food, and Exercise Sciences, Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Bahram H Arjmandi, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Arturo Figueroa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Sarah A Johnson, PhD, RD, CSO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.