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

Not Applicable

Completed

• Conditions: Elevated Blood Pressure; Hypertension
• Interventions: Other: Placebo; Other: Pumpkin Seed Oil

• Registration Number: NCT03716960
• Lead Sponsor: Marymount University

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.

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 Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-10
• Study First Submitted: 2018-10-20
• Study First Submitted QC: 2018-10-20
• Last Update Submitted: 2018-10-22
• Study First Posted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Pumpkin Seed Oil	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,

Primary Outcome Measures

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

Trial Locations

Locations (1)

Marymount University; 🇺🇸 Arlington, Virginia, United States