NCT02727036

Brief Summary

The purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on BP (systolic and diastolic), endothelial function, serum lipids, C-reactive protein (CRP) concentrations, and menopausal symptoms in postmenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

March 21, 2016

Last Update Submit

May 2, 2018

Conditions

HypertensionDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Change in systolic and diastolic blood pressure

    change measured - baseline and 12 weeks

Secondary Outcomes (6)

  • Change in Total Cholesterol level (mg/dl)

    change measured - baseline and 12 weeks

  • Change in Plasma Triglycerides (mg/dl)

    change measured - baseline and 12 weeks

  • Change in Plasma High-Density Lipoprotein Cholesterol (mg/dl)

    change measured - baseline and 12 weeks

  • Change in Plasma Low-Density Lipoprotein Cholesterol (mg/dl)

    change measured - baseline and 12 weeks

  • Change in C-reactive protein (CRP)

    change measured - baseline and 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Pumpkin seed oil

EXPERIMENTAL

Pumpkin seed oil (1g) capsules - 2 capsules per day for 12 weeks

Dietary Supplement: Pumpkin seed oil

Pumpkin seeds

ACTIVE COMPARATOR

Packet of pumpkin seeds (4.1 grams /\~0.15ounces) - 1 pack per day for 12 weeks

Dietary Supplement: Pumpkin seeds

Interventions

Pumpkin seed oilDIETARY_SUPPLEMENT

1 gram capsule of Pumpkin seed oil.

Pumpkin seed oil
Pumpkin seedsDIETARY_SUPPLEMENT

4.1 grams (1½ teaspoons/\~0.15ounces) of pumpkin seeds

Pumpkin seeds

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Non-hypertensive with blood pressure less than140/90 mmHg
  • Post menopausal women or had a bilateral oophorectomy

You may not qualify if:

  • Hypotensive women with BP \<90/60
  • Taking medications to manage blood pressure and blood lipids
  • Taking estrogen supplements or on hormone replacement therapy
  • Taking pumpkin seed oil supplements
  • Consuming pumpkin seeds more than ¼ cup a month
  • Diagnosed with depression and taking antidepressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Gossell-Williams M, Lyttle K, Clarke T, Gardner M, Simon O. Supplementation with pumpkin seed oil improves plasma lipid profile and cardiovascular outcomes of female non-ovariectomized and ovariectomized Sprague-Dawley rats. Phytother Res. 2008 Jul;22(7):873-7. doi: 10.1002/ptr.2381.

    PMID: 18567058RESULT

  • Gossell-Williams M, Hyde C, Hunter T, Simms-Stewart D, Fletcher H, McGrowder D, Walters CA. Improvement in HDL cholesterol in postmenopausal women supplemented with pumpkin seed oil: pilot study. Climacteric. 2011 Oct;14(5):558-64. doi: 10.3109/13697137.2011.563882. Epub 2011 May 5.

    PMID: 21545273RESULT

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Madhura Maiya, MS

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

  • Carolyn Moore, PhD

    Texas Woman's University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 4, 2016

Study Start

August 1, 2015

Primary Completion

June 16, 2017

Study Completion

November 10, 2017

Last Updated

May 3, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)