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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716960
• Other study ID #: 321
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: October 2018
• Source: Marymount University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension

Intervention

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
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.

Locations

Country	Name	City	State
United States	Marymount University	Arlington	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Marymount University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Non-invasive measures of brachial and aortic blood pressure	6 weeks
Primary	Pressure Wave Reflection	Using the augmentation index	6 weeks
Primary	Arterial Stiffness	Using the stiffness index	6 weeks
Primary	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