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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline

Completed

Started Feb 2013

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

February 1, 2013

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed

Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

March 26, 2014

Last Update Submit

December 15, 2016

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Keywords

Blood pressureArterial stiffnessPulse wave velocityStrawberriesEndothelial functionOxidative stressPostmenopausal women

Outcome Measures

Primary Outcomes (1)

Blood Pressure
By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
8 weeks

Secondary Outcomes (4)

Arterial Stiffness
8 weeks
Endothelial function
8 weeks
Oxidative Stress
8 weeks
Inflammation
8 weeks

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks

Dietary Supplement: Placebo Powder

25 g of Freeze-dried Strawberry Powder

ACTIVE COMPARATOR

Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks

Dietary Supplement: 25 g of Freeze-dried Strawberry PowderDietary Supplement: Placebo Powder

50 g of Freeze-dried Strawberry Powder

EXPERIMENTAL

Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks

Dietary Supplement: 50 g of Freeze-dried Strawberry Powder

Interventions

25 g of Freeze-dried Strawberry PowderDIETARY_SUPPLEMENT

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.

Also known as: California Strawberry Commission

25 g of Freeze-dried Strawberry Powder

50 g of Freeze-dried Strawberry PowderDIETARY_SUPPLEMENT

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.

Also known as: California Strawberry Commission

50 g of Freeze-dried Strawberry Powder

Placebo PowderDIETARY_SUPPLEMENT

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.

Also known as: California Strawberry Commission

25 g of Freeze-dried Strawberry PowderControl Group

Eligibility Criteria

Age45 Years - 65 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy)
years of age
Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/100 mm Hg
BMI \> 25 but \< 40 kg/m2

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Florida State Universitylead
California Strawberry Commissioncollaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

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.
PMID: 29099521DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular DiseasesVascular Diseases

Study Officials

Bahram H Arjmandi, PhD, RD
Florida State University
PRINCIPAL INVESTIGATOR
Arturo Figueroa, PhD
Florida State University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: FACTORIAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 31, 2014

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Control Group

25 g of Freeze-dried Strawberry Powder

50 g of Freeze-dried Strawberry Powder

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Study Officials

Study Design

Study Record Dates

Locations