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

May 2, 2018 updated by: Texas Woman's University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Woman's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in systolic and diastolic blood pressure
Time Frame: change measured - baseline and 12 weeks
change measured - baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Cholesterol level (mg/dl)
Time Frame: change measured - baseline and 12 weeks
change measured - baseline and 12 weeks
Change in Plasma Triglycerides (mg/dl)
Time Frame: change measured - baseline and 12 weeks
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 measured - baseline and 12 weeks
Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)
Time Frame: change measured - baseline and 12 weeks
change measured - baseline and 12 weeks
Change in C-reactive protein (CRP)
Time Frame: change measured - baseline and 12 weeks
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.).
change measured - baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Investigators

  • Principal Investigator: Madhura Maiya, MS, Texas Woman's University
  • Study Chair: Carolyn Moore, PhD, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

June 16, 2017

Study Completion (Actual)

November 10, 2017

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17696 (Other Identifier: REB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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