Pumpkin Seed Oil Supplementation in Premenopausal Women

June 17, 2015 updated by: Texas Woman's University

The Effect of Pumpkin Seed Oil Supplementation on Blood Pressure in Premenopausal Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research study will be conducted over a 12-week period. Overall, each participant will meet with the researcher three times. During the first visit, after the participant has signed the consent form, their blood pressure will be taken with a digital blood pressure monitor. If her systolic blood pressure is greater than 140 mmHg or her diastolic blood pressure is greater than 90 mmHg, she will not be eligible to take part in this study. If the participant is able to take part in this study, she will be given a code number to protect confidentiality and randomly assigned to one of two groups, Group I or Group II. The participant will then be asked to state their age, ethnicity, menopausal status, and whether or not they are taking oral contraceptives. Next, height and weight will be taken with an instrument called a Health-O-Meter. Body mass index (BMI) and percent body fat will be calculated using an instrument called a Body Composition Analyzer. After all measurements are taken, participants will be given instructions on how to keep a 3-day diet and supplement diary. A booklet will be provided to help them record their diet for two nonconsecutive week days and one weekend day. The 3-day diet and supplement diary is to be completed during the week between the first and second session with the researcher. During this session the participant will be asked to complete a food frequency questionnaire to help the researcher asses the phytoestrogen content of her diet. At the end of the first session, the researcher will schedule a second session with the participant.

The second session will take place one week after the first session. During the second session, measurements taken will be height, weight, BMI, percent body fat, and blood pressure. Participants will be asked to return the 3-day diet and supplement diary to the researcher. The researcher will review the diary and ask questions to clarify foods recorded. The participant will then be asked to complete a physical activity questionnaire. Next, supplements will be distributed. The participants will not have knowledge of which group they are assigned to. Group I will receive 168 capsules, each capsule containing 1 gram of wheat germ oil, in two pill bottles. One bottle will contain 100 capsules; the second bottle will contain 68 capsules. Group II will receive 168 capsules, each capsule containing 1 gram of pumpkin seed oil, in two pill bottles. One bottle will contain 100 capsules; the second bottle will contain 68 capsules. Participants will be instructed to take 2 capsules per day, every day for 12 weeks. Two capsules per day are equal to approximately a ½ teaspoon or 18 kilocalories. It does not matter if they choose to take each capsule at the same time or at different times during the day. To help remind participants to take their supplements each day, they will receive a 7 day pill organizer and a daily check list. At this session, participants will receive a second 3-day diet and supplement diary that is to be completed one week before the final session. At the end of the second session, the researcher will schedule the final session with the participant.

The third and final session will take place 12 weeks after the initial session. Measurements taken during the final session will be height, weight, BMI, percent body fat, and blood pressure. The participant will be asked to complete a food frequency questionnaire identical the questionnaire filled out during the first session with the researcher. Participant will be asked to return their 3-day diet and supplement diary, daily check list, pill organizer, 2 pill bottles, and any unused supplements. After completion of the study the participant will receive a $20 Target gift card at this session.

A potential risk of this study includes loss of confidentiality. Confidentiality will be maintained by the use of code numbers rather than names on data containing documents. Digital data analyses will be done using only code numbers and not identifiable data. Data recorded on paper containing identifiable and non-identifiable participant information (consent forms, data collection forms, 3-day diet and supplement diaries, physical activity questionnaires, food frequency questionnaires, and participant daily checklists) will be kept in a locked cabinet in Room 10132B in the Texas Woman's University, Houston Office of Research.

Another potential risk of this study may be that the participant's normal schedule is disrupted by coming to the Texas Woman's University, Houston campus. To minimize this risk, sessions will be scheduled with the researcher in advance Monday through Friday, from 8 a.m. to 5 p.m. to accommodate the participant's schedule.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Woman's University, Institute of Health Sciences- Houston Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Read, speak, and write English
  • Premenopausal

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Wheat Germ Oil
Participants will be instructed to consume 2 wheat germ oil capsules ,2g, per day for 12 weeks.
Dietary supplement: Wheat Germ Oil
2 grams per day, everyday for 12 weeks.
EXPERIMENTAL: Pumpkin Seed Oil
Participants will be instructed to consume 2 pumpkin seed oil capsules ,2g, per day for 12 weeks
Dietary supplement: Pumpkin Seed Oil
2 grams per day, everyday for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline Systolic Blood Pressure at 12 weeks
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks
Change From Baseline Diastolic Blood Pressure at 12 weeks
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Baseline
BMI is an important measurement to record because an increase in weight may be accompanied by an increase in blood pressure.
Baseline
Percent Body Fat
Time Frame: Baseline
Percent body fat is an important measurement to record because an increase in body fat may be accompanied by an increase in blood pressure.
Baseline
Nutrient content of diet
Time Frame: Baseline
Participants will be given instructions on how to keep a 3-day diet and supplement diary. A booklet will be provided to help them record their diet for two nonconsecutive week days and one weekend day. Diet will then be analyzed using Minnesota Nutrition Data System for calories, carbohydrate, protein, fat, vitamins, minerals, and phytoestrogen content.
Baseline
Phytoestrogen content of diet
Time Frame: Baseline
A food frequency questionnaire will be given to each participants to assess the phytoestrogen content of her diet.
Baseline
Activity Level
Time Frame: Baseline
The purpose of the physical activity questionnaire is to establish each participant's activity level because physical activity level may have an effect on blood pressure.
Baseline
Body Mass Index (BMI)
Time Frame: 12 weeks
BMI is an important measurement to record because an increase in weight may be accompanied by an increase in blood pressure.
12 weeks
Percent Body Fat
Time Frame: 12 weeks
Percent body fat is an important measurement to record because an increase in body fat may be accompanied by an increase in blood pressure.
12 weeks
Nutrient content of diet
Time Frame: 12 weeks
Participants will be given instructions on how to keep a 3-day diet and supplement diary. A booklet will be provided to help them record their diet for two nonconsecutive week days and one weekend day. Diet will then be analyzed using Minnesota Nutrition Data System for calories, carbohydrate, protein, fat, vitamins, minerals, and phytoestrogen content.
12 weeks
Phytoestrogen content of diet
Time Frame: 12 weeks
A food frequency questionnaire will be given to each participants to assess the phytoestrogen content of her diet.
12 weeks
Activity Level
Time Frame: 12 weeks
The purpose of the physical activity questionnaire is to establish each participant's activity level because physical activity level may have an effect on blood pressure.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Woman's University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samantha L Caudill, BS, Texas Woman's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17411a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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