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

Not Applicable

Completed

• Conditions: Hypertension; Dyslipidemia
• Interventions: Dietary Supplement: Pumpkin seed oil; Dietary Supplement: Pumpkin seeds

• Registration Number: NCT02727036
• Lead Sponsor: Texas Woman's University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-04
• Primary Completion: 2017-06-16
• Study Completion: 2017-11-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pumpkin seed oil	Pumpkin seed oil	Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks
Pumpkin seeds	Pumpkin seeds	Packet of pumpkin seeds (4.1 grams /\~0.15ounces) - 1 pack per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure	change measured - baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)	change measured - baseline and 12 weeks	High-density Lipoprotein-C
Change in Endothelial Function	change measured - baseline and 12 weeks	Endothelial function will be assessed using a computer based non-invasive peripheral arterial tonometer (Endo-PAT 2000, Itamar Medical Ltd.).
Change in Total Cholesterol level (mg/dl)	change measured - baseline and 12 weeks
Change in Plasma Triglycerides (mg/dl)	change measured - baseline and 12 weeks
Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)	change measured - baseline and 12 weeks
Change in C-reactive protein (CRP)	change measured - baseline and 12 weeks

Trial Locations

Locations (1)

Texas Woman's University; 🇺🇸 Houston, Texas, United States