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OpenTrials
Completed

NCT Number: NCT03716960

The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular 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.

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Key information

Conditions

Elevated Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marymount University

Arlington, Virginia, 22207, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pumpkin Seed Oil

Other

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

Other

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.

Primary outcomes

  1. Blood pressure

    Time frame: 6 weeks

    Non-invasive measures of brachial and aortic blood pressure

  2. Pressure Wave Reflection

    Time frame: 6 weeks

    Using the augmentation index

  3. Arterial Stiffness

    Time frame: 6 weeks

    Using the stiffness index

  4. Heart rate variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marymount University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 23, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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