The Effects of Strawberries on Blood Pressure in Postmenopausal Women
NCT ID: NCT02099578
Last Updated: 2016-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2013-02-28
2014-07-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Control Group
Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks
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.
25 g of Freeze-dried Strawberry Powder
Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks
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.
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.
50 g of Freeze-dried Strawberry Powder
Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
45 Years
65 Years
FEMALE
No
Sponsors
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California Strawberry Commission
OTHER
Florida State University
OTHER
Responsible Party
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Bahram Arjmandi
Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging
Principal Investigators
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Bahram H Arjmandi, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Florida State University
Arturo Figueroa, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida State University
Locations
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Florida State University
Tallahassee, Florida, United States
Countries
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References
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Feresin RG, Johnson SA, Pourafshar S, Campbell JC, Jaime SJ, Navaei N, Elam ML, Akhavan NS, Alvarez-Alvarado S, Tenenbaum G, Brummel-Smith K, Salazar G, Figueroa A, Arjmandi BH. Impact of daily strawberry consumption on blood pressure and arterial stiffness in pre- and stage 1-hypertensive postmenopausal women: a randomized controlled trial. Food Funct. 2017 Nov 15;8(11):4139-4149. doi: 10.1039/c7fo01183k.
Other Identifiers
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2013.11762
Identifier Type: -
Identifier Source: org_study_id