The Effects of Strawberries on Blood Pressure in Postmenopausal Women

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

Tracking Information

• First Submitted Date: March 26, 2014
• First Posted Date: March 31, 2014
• Last Update Posted Date: December 16, 2016
• Study Start Date: February 2013
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Hypertension
• Cardiovascular Diseases
• Vascular Diseases

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 26, 2014): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02099578
• Other Study ID Numbers: 2013.11762
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Bahram Arjmandi, Florida State University
• Original Responsible Party: Florida State University
• Current Study Sponsor: Florida State University
• Original Study Sponsor: Same as current
• Collaborators: California Strawberry Commission

Investigators

• 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