We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 21, 2016
First Posted Date  ICMJE April 4, 2016
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE August 1, 2015
Actual Primary Completion Date June 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
Change in systolic and diastolic blood pressure [ Time Frame: change measured - baseline and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2016)
  • 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.).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pumpkin Seed Oil or Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Postmenopausal Women
Official Title  ICMJE Effect of Supplementation With Pumpkin Seed Oil Versus Pumpkin Seeds on Blood Pressure and Menopausal Symptoms in Non-hypertensive Postmenopausal Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Dyslipidemia
Intervention  ICMJE
  • Dietary Supplement: Pumpkin seed oil
    1 gram capsule of Pumpkin seed oil.
  • Dietary Supplement: Pumpkin seeds
    4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds
Study Arms  ICMJE
  • Experimental: Pumpkin seed oil
    Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks
    Intervention: Dietary Supplement: Pumpkin seed oil
  • Active Comparator: Pumpkin seeds
    Packet of pumpkin seeds (4.1 grams /~0.15ounces) - 1 pack per day for 12 weeks
    Intervention: Dietary Supplement: Pumpkin seeds
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
27
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2016)
58
Actual Study Completion Date  ICMJE November 10, 2017
Actual Primary Completion Date June 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02727036
Other Study ID Numbers  ICMJE 17696
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Texas Woman's University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Texas Woman's University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madhura Maiya, MS Texas Woman's University
Study Chair: Carolyn Moore, PhD Texas Woman's University
PRS Account Texas Woman's University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP