The Effects of Strawberries on Blood Pressure in Postmenopausal Women

Not Applicable

Completed

• Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Interventions: Dietary Supplement: 50 g of Freeze-dried Strawberry Powder; Dietary Supplement: 25 g of Freeze-dried Strawberry Powder; Dietary Supplement: Placebo Powder

• Registration Number: NCT02099578
• Lead Sponsor: Florida State University

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (BP) in women after menopause exceeds that of men.

The development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. One such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life.

Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.

Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three groups:

1. 25 g freeze-dried strawberry powder;

2. 50 g freeze-dried strawberry powder; or

3. placebo powder. Participants will be asked to consume the supplements for 8-weeks. Medical history, medication use, dietary intake, and physical activity will be assessed at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular function as well as oxidative stress and inflammation will be measured.

The investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease BP and blood markers of oxidative stress as well as inflammation. Investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy)
• 45-65 years of age
• Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/100 mm Hg
• BMI > 25 but < 40 kg/m2

Exclusion Criteria

• Seated blood pressure ≤ 129/84 or ≥160/101 mmHg
• Type I Diabetes
• Cardiovascular disease
• Active cancer
• Glaucoma
• Thyroid disease
• Kidney disease
• Liver disease
• Pancreatic disease
• Enrollment in a weight loss program
• Heavy smokers (>20 cigarettes per day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
25 g of Freeze-dried Strawberry Powder	Placebo Powder	Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks
50 g of Freeze-dried Strawberry Powder	50 g of Freeze-dried Strawberry Powder	Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks
Control Group	Placebo Powder	Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks
25 g of Freeze-dried Strawberry Powder	25 g of Freeze-dried Strawberry Powder	Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks

Primary Outcome Measures

Name	Time	Method
Blood Pressure	8 weeks	By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

Secondary Outcome Measures

Name	Time	Method
Arterial Stiffness	8 weeks	By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Oxidative Stress	8 weeks	By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).
Endothelial function	8 weeks	By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
Inflammation	8 weeks	By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States