NCT02119429

Brief Summary

The purpose of this study is to determine whether or not there is an effect of pumpkin seed oil supplementation, 2 grams per day, on blood pressure (systolic and diastolic) in premenopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

April 15, 2014

Last Update Submit

June 17, 2015

Conditions

Blood Pressure

Keywords

Blood pressurePre-menopausalSupplementation

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline Systolic Blood Pressure at 12 weeks

    Baseline, 12 weeks

  • Change From Baseline Diastolic Blood Pressure at 12 weeks

    Baseline, 12 weeks

Secondary Outcomes (10)

  • Body Mass Index (BMI)

    Baseline

  • Percent Body Fat

    Baseline

  • Nutrient content of diet

    Baseline

  • Phytoestrogen content of diet

    Baseline

  • Activity Level

    Baseline

  • +5 more secondary outcomes

Study Arms (2)

Wheat Germ Oil

PLACEBO COMPARATOR

Participants will be instructed to consume 2 wheat germ oil capsules ,2g, per day for 12 weeks.

Dietary Supplement: Wheat Germ Oil

Pumpkin Seed Oil

EXPERIMENTAL

Participants will be instructed to consume 2 pumpkin seed oil capsules ,2g, per day for 12 weeks

Dietary Supplement: Pumpkin Seed Oil

Interventions

Pumpkin Seed OilDIETARY_SUPPLEMENT

2 grams per day, everyday for 12 weeks.

Pumpkin Seed Oil
Wheat Germ OilDIETARY_SUPPLEMENT

2 grams per day, everyday for 12 weeks.

Wheat Germ Oil

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Read, speak, and write English
  • Premenopausal

You may not qualify if:

  • Consuming estrogen supplements
  • Taking hypertensive blood pressure medication
  • Consuming pumpkin seed oil supplements
  • Consuming pumpkin seeds more than once a month
  • Wheat allergy or gluten intolerance
  • Blood pressure \> 140/90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University, Institute of Health Sciences- Houston Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

wheat germ oil

Study Officials

  • Samantha L Caudill, BS

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 21, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 18, 2015

Record last verified: 2014-12

Locations

US(1)