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NCT Number: NCT02099578

The Effects of Strawberries on Blood Pressure in Postmenopausal Women

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

25 g of Freeze-dried Strawberry Powder

Dietary Supplement

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.

Other names: California Strawberry Commission

50 g of Freeze-dried Strawberry Powder

Dietary Supplement

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.

Other names: California Strawberry Commission

Placebo Powder

Dietary Supplement

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.

Other names: California Strawberry Commission

Primary outcomes

  1. Blood Pressure

    Time frame: 8 weeks

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

Secondary outcomes

  1. Arterial Stiffness

    Time frame: 8 weeks

    By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  2. Endothelial function

    Time frame: 8 weeks

    By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).

  3. Oxidative Stress

    Time frame: 8 weeks

    By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).

  4. Inflammation

    Time frame: 8 weeks

    By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • California Strawberry Commission

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 31, 2014
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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