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

The Effects of Pumpkin Seed Oil Supplementation on Vascular Hemodynamics, Stiffness and Cardiac Autonomic Function in Postmenopausal Women.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Elevated Blood Pressure
• Intervention / Treatment: Other: Pumpkin Seed Oil; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Arlington, Virginia, United States, 22207
      • Marymount University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Non-invasive measures of brachial and aortic blood pressure	6 weeks
Pressure Wave Reflection	Using the augmentation index	6 weeks
Arterial Stiffness	Using the stiffness index	6 weeks
Heart rate variability	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.	6 weeks

Collaborators and Investigators

• Sponsor: Marymount University
• Investigators: Principal Investigator: Alexei Wong, Ph.D, Marymount University

Publications and helpful links

General Publications

• Wong A, Viola D, Bergen D, Caulfield E, Mehrabani J, Figueroa A. The effects of pumpkin seed oil supplementation on arterial hemodynamics, stiffness and cardiac autonomic function in postmenopausal women. Complement Ther Clin Pract. 2019 Nov;37:23-26. doi: 10.1016/j.ctcp.2019.08.003. Epub 2019 Aug 8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: October 20, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 321

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No