The Effects of Strawberries on Blood Pressure in Postmenopausal Women

NCT ID: NCT02099578

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Hypertension Cardiovascular Diseases Vascular Diseases

Keywords

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Blood pressure Arterial stiffness Pulse wave velocity Strawberries Endothelial function Oxidative stress Postmenopausal women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

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

Group Type PLACEBO_COMPARATOR

Placebo Powder

Intervention Type DIETARY_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.

25 g of Freeze-dried Strawberry Powder

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

Group Type ACTIVE_COMPARATOR

25 g of Freeze-dried Strawberry Powder

Intervention Type DIETARY_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.

Placebo Powder

Intervention Type DIETARY_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.

50 g of Freeze-dried Strawberry Powder

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

Group Type EXPERIMENTAL

50 g of Freeze-dried Strawberry Powder

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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California Strawberry Commission California Strawberry Commission California Strawberry Commission

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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California Strawberry Commission

OTHER

Sponsor Role collaborator

Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Bahram Arjmandi

Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bahram H Arjmandi, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Arturo Figueroa, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29099521 (View on PubMed)

Other Identifiers

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2013.11762

Identifier Type: -

Identifier Source: org_study_id