Clinical trial NCT02099578: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Vascular Diseases
Keywords: Blood pressure
Arterial stiffness
Pulse wave velocity
Strawberries
Endothelial function
Oxidative stress
Postmenopausal women
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: California Strawberry Commission
First posted: 2014-03-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: 8 weeks
measure: Endothelial function
timeFrame: 8 weeks
measure: Oxidative Stress
timeFrame: 8 weeks
measure: Inflammation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Bahram H Arjmandi, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Arturo Figueroa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.