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The Effects of Strawberries on Blood Pressure in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02099578
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
Bahram Arjmandi, Florida State University

Tracking Information
First Submitted Date  ICMJE March 26, 2014
First Posted Date  ICMJE March 31, 2014
Last Update Posted Date December 16, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
  • 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).
  • Endothelial function [ Time Frame: 8 weeks ]
    By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
  • 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).
  • Inflammation [ Time Frame: 8 weeks ]
    By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Strawberries on Blood Pressure in Postmenopausal Women
Official Title  ICMJE Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension
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:

  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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Cardiovascular Diseases
  • Vascular Diseases
Intervention  ICMJE
  • 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.
    Other Name: California Strawberry Commission
  • 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.
    Other Name: California Strawberry Commission
  • 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.
    Other Name: California Strawberry Commission
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks
    Intervention: Dietary Supplement: Placebo Powder
  • Active Comparator: 25 g of Freeze-dried Strawberry Powder
    Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks
    Interventions:
    • Dietary Supplement: 25 g of Freeze-dried Strawberry Powder
    • Dietary Supplement: Placebo Powder
  • Experimental: 50 g of Freeze-dried Strawberry Powder
    Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks
    Intervention: Dietary Supplement: 50 g of Freeze-dried Strawberry Powder
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02099578
Other Study ID Numbers  ICMJE 2013.11762
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Bahram Arjmandi, Florida State University
Original Responsible Party Florida State University
Current Study Sponsor  ICMJE Florida State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE California Strawberry Commission
Investigators  ICMJE
Principal Investigator: Bahram H Arjmandi, PhD, RD Florida State University
Principal Investigator: Arturo Figueroa, PhD Florida State University
PRS Account Florida State University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP