Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT02727036|
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Dyslipidemia||Dietary Supplement: Pumpkin seed oil Dietary Supplement: Pumpkin seeds||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||June 16, 2017|
|Actual Study Completion Date :||November 10, 2017|
Experimental: Pumpkin seed oil
Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks
Dietary Supplement: Pumpkin seed oil
1 gram capsule of Pumpkin seed oil.
Active Comparator: Pumpkin seeds
Packet of pumpkin seeds (4.1 grams /~0.15ounces) - 1 pack per day for 12 weeks
Dietary Supplement: Pumpkin seeds
4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds
- Change in systolic and diastolic blood pressure [ Time Frame: change measured - baseline and 12 weeks ]
- Change in Total Cholesterol level (mg/dl) [ Time Frame: change measured - baseline and 12 weeks ]
- Change in Plasma Triglycerides (mg/dl) [ Time Frame: change measured - baseline and 12 weeks ]
- Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl) [ Time Frame: change measured - baseline and 12 weeks ]High-density Lipoprotein-C
- Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl) [ Time Frame: change measured - baseline and 12 weeks ]
- Change in C-reactive protein (CRP) [ Time Frame: change measured - baseline and 12 weeks ]
- Change in Endothelial Function [ Time Frame: 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.).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727036
|United States, Texas|
|Texas Woman's University|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Madhura Maiya, MS||Texas Woman's University|
|Study Chair:||Carolyn Moore, PhD||Texas Woman's University|