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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Elevated Blood Pressure, Hypertension

Intervention / Treatment
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* Other: Pumpkin Seed Oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pumpkin Seed Oil<br>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<br>* 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).<br>|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|

What is the study measuring?
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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 |