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The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular Function in Postmenopausal Women.

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ClinicalTrials.gov Identifier: NCT03716960
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Alexei Wong, Marymount University

Study Description
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Brief Summary:

Postmenopausal women have a higher prevalence of cardiovascular (CV) disease than age-match men. Growing evidence from rat studies have demonstrated CV-protective effects of pumpkin seed oil (PSO).

The investigators hypothesis is that PSO would improve CV health in postmenopausal women.


Condition or disease Intervention/treatment Phase
Elevated Blood Pressure Hypertension Other: Pumpkin Seed Oil Other: Placebo Not Applicable

Detailed Description:

The purpose of the study is to examine the effects of 6 weeks of PSO on arterial and autonomic function in postmenopausal women. Specific aims of the study are to:

To investigate the extent to which PSO will improve cardiovascular disease risk factors by assessing arterial stiffness, aortic BP and wave reflection, and autonomic function (heart rate variability).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effects of Pumpkin Seed Oil Supplementation on Vascular Hemodynamics, Stiffness and Cardiac Autonomic Function in Postmenopausal Women.
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pumpkin Seed Oil
This arm involved 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner). Likewise,
 Other: Pumpkin Seed Oil
This intervention consisted of 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner).
Placebo Comparator: Placebo
This arm involved 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.
 Other: Placebo
This intervention consisted of 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 6 weeks ]
    Non-invasive measures of brachial and aortic blood pressure

  2. Pressure Wave Reflection [ Time Frame: 6 weeks ]
    Using the augmentation index

  3. Arterial Stiffness [ Time Frame: 6 weeks ]
    Using the stiffness index

  4. Heart rate variability [ Time Frame: 6 weeks ]
    R-R intervals were collected during 6 min using a validated wireless monitor (Polar 800CX; Polar Electro OY, Kempele, Finland) via a chest strap interfaced with a PC. All R-R intervals were inspected for artifacts and premature beats.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 45 to 65 years of age
  • At least 1 year after menopause
  • BMI <39.9
  • Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

  • known heart disease
  • peripheral vascular disease
  • diabetes, body mass index
  • BMI> 40 kg/m2
  • other chronic diseases
  • taking medications (e.g., hormone replacement therapy, beta blockers, calcium channel blockers, antidepressants and stimulants) that could affect the outcome variables
  • smokers
  • history of steady exercise or received exercise training and dietary changes in the last year
Contacts and Locations
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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): NCT03716960


Locations
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United States, Virginia
Marymount University
Arlington, Virginia, United States, 22207
Sponsors and Collaborators
Marymount University
Investigators
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Principal Investigator: Alexei Wong, Ph.D Marymount University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alexei Wong, Assistant Professor, Marymount University
ClinicalTrials.gov Identifier: NCT03716960    
Other Study ID Numbers: 321
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases