The Effects of Strawberries on Blood Pressure in Postmenopausal Women
Primary Purpose
Hypertension, Cardiovascular Diseases, Vascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
25 g of Freeze-dried Strawberry Powder
50 g of Freeze-dried Strawberry Powder
Placebo Powder
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Blood pressure, Arterial stiffness, Pulse wave velocity, Strawberries, Endothelial function, Oxidative stress, Postmenopausal women
Eligibility Criteria
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)
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Control Group
25 g of Freeze-dried Strawberry Powder
50 g of Freeze-dried Strawberry Powder
Arm Description
Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks
Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks
Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks
Outcomes
Primary Outcome Measures
Blood Pressure
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Secondary Outcome Measures
Arterial Stiffness
By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Endothelial function
By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
Oxidative Stress
By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).
Inflammation
By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).
Full Information
NCT ID
NCT02099578
First Posted
March 26, 2014
Last Updated
December 15, 2016
Sponsor
Florida State University
Collaborators
California Strawberry Commission
1. Study Identification
Unique Protocol Identification Number
NCT02099578
Brief Title
The Effects of Strawberries on Blood Pressure in Postmenopausal Women
Official Title
Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
California Strawberry Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
25 g freeze-dried strawberry powder;
50 g freeze-dried strawberry powder; or
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases, Vascular Diseases
Keywords
Blood pressure, Arterial stiffness, Pulse wave velocity, Strawberries, Endothelial function, Oxidative stress, Postmenopausal women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks
Arm Title
25 g of Freeze-dried Strawberry Powder
Arm Type
Active Comparator
Arm Description
Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks
Arm Title
50 g of Freeze-dried Strawberry Powder
Arm Type
Experimental
Arm Description
Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
25 g of Freeze-dried Strawberry Powder
Other Intervention Name(s)
California Strawberry Commission
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
50 g of Freeze-dried Strawberry Powder
Other Intervention Name(s)
California Strawberry Commission
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Powder
Other Intervention Name(s)
California Strawberry Commission
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
Time Frame
8 weeks
Title
Endothelial function
Description
By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
Time Frame
8 weeks
Title
Oxidative Stress
Description
By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein).
Time Frame
8 weeks
Title
Inflammation
Description
By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahram H Arjmandi, PhD, RD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arturo Figueroa, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29099521
Citation
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.
Results Reference
derived
Learn more about this trial
The Effects of Strawberries on Blood Pressure in Postmenopausal Women
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