The Effects of Strawberries on Blood Pressure in Postmenopausal Women
NCT02099578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2016-12-16
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.
Conditions
- Hypertension
- Cardiovascular Diseases
- Vascular Diseases
Interventions
- 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.
- DIETARY_SUPPLEMENT
-
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.
- DIETARY_SUPPLEMENT
-
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.
Sponsors & Collaborators
-
California Strawberry Commission
collaborator OTHER -
Florida State University
lead OTHER
Principal Investigators
-
Bahram H Arjmandi, PhD, RD · Florida State University
-
Arturo Figueroa, PhD · Florida State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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