The Effects of Strawberries on Blood Pressure in Postmenopausal Women

Hypertension Clinical Trial

Official title:

Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099578
• Other study ID #: 2013.11762
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: December 15, 2016
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Dietary Supplement:
• 25 g of Freeze-dried Strawberry Powder
Participants will be given one packet of 25 g of freeze-dried strawberry powder and one packet of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
• 50 g of Freeze-dried Strawberry Powder
Participants will be given two packets of 25 g of freeze-dried strawberry powder and asked to consume one packet in the morning and one at night.
• Placebo Powder
Participants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	California Strawberry Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).	8 weeks	No
Secondary	Arterial Stiffness	By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).	8 weeks	No
Secondary	Endothelial function	By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).	8 weeks	No
Secondary	Oxidative Stress	By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).	8 weeks	No
Secondary	Inflammation	By assessing blood biomarkers of inflammation (tumor necrosis factor-a and C-reactive protein).	8 weeks	No