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Completed

NCT Number: NCT02727036

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pumpkin seed oil

Dietary Supplement

1 gram capsule of Pumpkin seed oil.

Pumpkin seeds

Dietary Supplement

4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds

Primary outcomes

  1. Change in systolic and diastolic blood pressure

    Time frame: change measured - baseline and 12 weeks

Secondary outcomes

  1. Change in Total Cholesterol level (mg/dl)

    Time frame: change measured - baseline and 12 weeks

  2. Change in Plasma Triglycerides (mg/dl)

    Time frame: change measured - baseline and 12 weeks

  3. Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)

    Time frame: change measured - baseline and 12 weeks

    High-density Lipoprotein-C

  4. Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)

    Time frame: change measured - baseline and 12 weeks

  5. Change in C-reactive protein (CRP)

    Time frame: change measured - baseline and 12 weeks

  6. 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.).

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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