Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants

PRIMARY OBJECTIVES:

I. Feasibility of fostering adherence to self-monitoring of dietary intake using a smartphone
application (app).

II. Feasibility of the goal of following a time-restricted diet.

SECONDARY OBJECTIVES:

I. Identify potential molecular biomarkers and/or signatures to explore its efficacy for the
normalization of metabolism.

II. Assess the systemic endocrine effects of a time restricted diet (tRD) intervention in
overweight and obese pre and postmenopausal women.

III. Assess weight change following a tRD intervention. IV. Evaluate the effects of a tRD
intervention, and identify a specific and reproducible genomic signature, in breast samples
obtained by random fine needle aspiration in the tRD study population.

V. Assess the volume of parenchymal enhancement on magnetic resonance imaging (MRI).

OUTLINE:

Participants follow a time restricted diet, which restricts daily eating to an 8 hour time
window between 12:00-8:00 pm. Participants are allowed to consume non-caloric beverages
(water, black tea, black coffee, diet soda, etc.) during the fasting hours and required to
record daily food consumption in the smartphone app for 6 months. Participants are also
coached by telephone over approximately 10-15 minutes weekly for 1 month and then biweekly
for 5 months.

After completion, participants are followed up for 3 months.

Inclusion Criteria:

- Subjects must have a stable weight (have not gained or lost 25 pounds in the last 6
months)

- Subjects must have had a normal mammogram within 9 months prior to registration; NOTE:
subjects must also have a normal breast exam on the day of the pre-intervention random
fine needle aspiration (rFNA)

- Subjects must have a body mass index (BMI) of 25-40

- Subjects must fit into ONE of the following menopausal categories:

- Premenopausal (n = 40) - defined as meeting all the following criteria:

- Have had at least 8 menstrual cycles in the past 12 months

- Have had no hormonal contraception in the past 3 months prior to
registration

- Have serum hormone parameters (estradiol [E2], progesterone, follicle
stimulating hormone [FSH]) in premenopausal range on the day of rFNA; NOTE:
subjects will self-report menopausal status at registration, and
confirmation of hormonal parameters will occur after registration as part of
pre-intervention procedures; if there is mis-assignment of status, the
recruitment of future subjects will be adjusted accordingly

- Postmenopausal (n = 40) - defined as meeting all of the following criteria:

- Last menstrual period (LMP) > 1 year previously

- Have had no hormone use in the past 3 months prior to registration

- Serum E2, progesterone, FSH in postmenopausal range on the day of rFNA;
NOTE: subjects will self-report menopausal status at registration, and
confirmation of hormonal parameters will occur after registration as part of
pre-intervention procedures; if there is mis-assignment of status, the
recruitment of future subjects will be adjusted accordingly

- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0 or 1

- Subjects who have been diagnosed with a prior cancer at any site (other than breast
cancer) may participate as long as they have been off medical therapy for at least 12
months prior to registration

- Subjects with prior breast cancer must be off all systemic therapy (including
endocrine agents) for at least 2 years prior to registration

- Subjects must be willing to undergo a random fine needle aspiration (rFNA) at the
beginning and end of the intervention period

- Subjects must be willing and able to abstain from the use of aspirin for at least 2
weeks prior to undergoing each rFNA procedure (pre- and post-intervention)

- Subjects must have the ability to understand and the willingness to sign a written
informed consent prior to registration on study

- Subjects must have a smart phone (newer generation Android or any Iphone) to be able
to track their food intake times

- Subjects must be willing to restrict food intake to an 8 hour period every day (12 pm
to 8 pm)

Exclusion Criteria:

- Subjects who have received hormonal contraception and/or hormone therapy in the past 3
months are not eligible

- Subjects who are pregnant and/or lactating are not eligible

- Subjects who are noted (upon initial online screening) to do 150 minutes or more of
moderate level physical activity each week, get less than 8% of their calories from
saturated fat, and eat more than 5 fruit and vegetable servings per day will not be
eligible

- Subjects who are part of any structured weight loss programs (e.g. Weight Watchers,
etc.) are not eligible

- Subjects who have undergone bariatric surgery are not eligible

- Subjects who work night shifts are not eligible

- Subjects who have diabetes or uncontrolled hypertension are not eligible; NOTE: for
the purposes of this study, uncontrolled will be defined as diastolic pressure over
100 mmHg