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

NCT03716960 | Completed

• 1 other identifier: 321
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Pumpkin Seed Oil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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).

Pumpkin Seed Oil

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.

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• to 65 years of age
• At least 1 year after menopause
• BMI \<39.9
• Sedentary or low active (less than 2 hr per wk)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marymount University: lead

Study Sites (1)

Marymount University

Arlington, Virginia, 22207, United States

Location

Related Publications (1)

• Wong A, Viola D, Bergen D, Caulfield E, Mehrabani J, Figueroa A. The effects of pumpkin seed oil supplementation on arterial hemodynamics, stiffness and cardiac autonomic function in postmenopausal women. Complement Ther Clin Pract. 2019 Nov;37:23-26. doi: 10.1016/j.ctcp.2019.08.003. Epub 2019 Aug 8.

  PMID: 31445363 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexei Wong, Ph.D

  Marymount University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 23, 2018
• Study Start: September 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (1)