Clinical trial NCT02727036: Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women
Official title: Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: change measured - baseline and 12 weeks
Secondary outcomes:
measure: Change in Total Cholesterol level (mg/dl)
timeFrame: change measured - baseline and 12 weeks
measure: Change in Plasma Triglycerides (mg/dl)
timeFrame: change measured - baseline and 12 weeks
measure: Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)
timeFrame: change measured - baseline and 12 weeks
measure: Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)
timeFrame: change measured - baseline and 12 weeks
measure: Change in C-reactive protein (CRP)
timeFrame: change measured - baseline and 12 weeks
measure: Change in Endothelial Function
timeFrame: change measured - baseline and 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Madhura Maiya, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Woman's University
name: Carolyn Moore, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.