Pumpkin Seed Oil Supplementation 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