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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03716960
Other study ID # 321
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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