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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727036
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University

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.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Dietary Supplement: Pumpkin seed oil Dietary Supplement: Pumpkin seeds Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in systolic and diastolic blood pressure [ Time Frame: change measured - baseline and 12 weeks ]

Secondary Outcome Measures :
  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.).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Texas
Texas Woman's University
Houston, Texas, United States, 77030
Sponsors and Collaborators
Texas Woman's University
Investigators
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Principal Investigator: Madhura Maiya, MS Texas Woman's University
Study Chair: Carolyn Moore, PhD Texas Woman's University
Publications of Results:
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Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT02727036    
Other Study ID Numbers: 17696
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases