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

Study Overview
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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.

Official Title
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Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women

Conditions
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Hypertension, Dyslipidemia

Intervention / Treatment
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* Dietary Supplement: Pumpkin seed oil
* Dietary Supplement: Pumpkin seeds


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pumpkin seed oil<br>Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks | Dietary Supplement: Pumpkin seed oil<br>* 1 gram capsule of Pumpkin seed oil.<br>|
| Active Comparator: Pumpkin seeds<br>Packet of pumpkin seeds (4.1 grams / 0.15ounces) - 1 pack per day for 12 weeks | Dietary Supplement: Pumpkin seeds<br>* 4.1 grams (1½ teaspoons/ 0.15ounces) of pumpkin seeds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic and diastolic blood pressure |  | change measured - baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 High-Density Lipoprotein Cholesterol (mg/dl) | High-density Lipoprotein-C | 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 | 
| Change in Endothelial Function | Endothelial function will be assessed using a computer based non-invasive peripheral arterial tonometer (Endo-PAT 2000, Itamar Medical Ltd.). | change measured - baseline and 12 weeks |