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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727036
• Other study ID #: 17696
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: November 10, 2017

Study information

• Verified date: May 2018
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 10, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Dietary Supplement:
• Pumpkin seed oil
1 gram capsule of Pumpkin seed oil.
• Pumpkin seeds
4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds

Locations

Country	Name	City	State
United States	Texas Woman's University	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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: 10.3109/13697137.2 — View 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic and diastolic blood pressure		change measured - baseline and 12 weeks
Secondary	Change in Total Cholesterol level (mg/dl)		change measured - baseline and 12 weeks
Secondary	Change in Plasma Triglycerides (mg/dl)		change measured - baseline and 12 weeks
Secondary	Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)	High-density Lipoprotein-C	change measured - baseline and 12 weeks
Secondary	Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)		change measured - baseline and 12 weeks
Secondary	Change in C-reactive protein (CRP)		change measured - baseline and 12 weeks
Secondary	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