Pumpkin Seed Oil Supplementation in Premenopausal Women
Pumpkin Seed Oil Supplementation 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.
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.
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