Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women

NCT ID: NCT02727036

Last Updated: 2018-05-03

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-11-10

Brief Summary

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The purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function, serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in postmenopausal women.

Detailed Description

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At the onset of menopause CVD rates increase in women. A beneficial effect of pumpkin seed oil on blood pressure has been observed in postmenopausal women. More than 1 in 3 female adults have some form of cardiovascular disease (CVD), which is affected by blood pressure.

Pumpkin seed is a good source of phytoestrogens. Phytoestrogens are compounds found in plants and are comparable to human estrogen, capable of producing estrogenic effects. Studies in post menopausal women have demonstrated that pumpkin seed oil, at a dose of 2g per day for 12 weeks can decrease blood pressure and reduce menopausal symptoms.

Conditions

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Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pumpkin seed oil

Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks

Group Type EXPERIMENTAL

Pumpkin seed oil

Intervention Type DIETARY_SUPPLEMENT

1 gram capsule of Pumpkin seed oil.

Pumpkin seeds

Packet of pumpkin seeds (4.1 grams /\~0.15ounces) - 1 pack per day for 12 weeks

Group Type ACTIVE_COMPARATOR

Pumpkin seeds

Intervention Type DIETARY_SUPPLEMENT

4.1 grams (1½ teaspoons/\~0.15ounces) of pumpkin seeds

Interventions

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Pumpkin seed oil

1 gram capsule of Pumpkin seed oil.

Intervention Type DIETARY_SUPPLEMENT

Pumpkin seeds

4.1 grams (1½ teaspoons/\~0.15ounces) of pumpkin seeds

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Non-hypertensive with blood pressure less than140/90 mmHg
* Post menopausal women or had a bilateral oophorectomy

Exclusion Criteria

* Hypotensive women with BP \<90/60
* Taking medications to manage blood pressure and blood lipids
* Taking estrogen supplements or on hormone replacement therapy
* Taking pumpkin seed oil supplements
* Consuming pumpkin seeds more than ¼ cup a month
* Diagnosed with depression and taking antidepressants
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madhura Maiya, MS

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Carolyn Moore, PhD

Role: STUDY_CHAIR

Texas Woman's University

Locations

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Texas Woman's University

Houston, Texas, United States

Site Status

Countries

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United States

References

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Gossell-Williams M, Lyttle K, Clarke T, Gardner M, Simon O. Supplementation with pumpkin seed oil improves plasma lipid profile and cardiovascular outcomes of female non-ovariectomized and ovariectomized Sprague-Dawley rats. Phytother Res. 2008 Jul;22(7):873-7. doi: 10.1002/ptr.2381.

Reference Type RESULT
PMID: 18567058 (View on PubMed)

Gossell-Williams M, Hyde C, Hunter T, Simms-Stewart D, Fletcher H, McGrowder D, Walters CA. Improvement in HDL cholesterol in postmenopausal women supplemented with pumpkin seed oil: pilot study. Climacteric. 2011 Oct;14(5):558-64. doi: 10.3109/13697137.2011.563882. Epub 2011 May 5.

Reference Type RESULT
PMID: 21545273 (View on PubMed)

Other Identifiers

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17696

Identifier Type: -

Identifier Source: org_study_id

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