Clinical trial NCT02154984: Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants
Official title: A Pilot Study of Time Restricted Diet in Obese/Overweight Pre &Amp; Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy, no Evidence of Disease
Obesity
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Avon Foundation Center of Excellence
name: National Cancer Institute (NCI)
First posted: 2014-06-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the relationships between obesity, hormones and menopausal status, and breast cancer. The researchers would like to study whether a type of nutritional intervention, called a time-restricted diet or tRD, is easy to maintain using a smartphone application; the researchers also want to study the effect that a tRD has on weight control, hormones, and breast tissue. A tRD is a type of diet that requires people to restrict their daily eating to a specific time frame each day. The researchers think that this might be an effective and manageable way to control weight.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to self-monitoring
timeFrame: Up to 3 months after completion of study
measure: Attaining the goal of dietary time restriction
timeFrame: Up to 3 months after completion of study
Secondary outcomes:
measure: Changes in steroid hormones (estradiol, progesterone, testosterone) levels
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in gonadotropins (FSH) levels
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in insulin axis (insulin, insulin-like growth factor 1, IGF binding protein 3, homeostatic model assessment, homocystein) levels
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in adipokines (leptin, adiponectin, low molecular weight adiponectin) levels
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in inflammatory axis (interleukin-6, tumor necrosis factor alpha) levels
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in weight
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in BMI
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in breast epithelial gene expression
timeFrame: Baseline to up to 3 months after completion of study
measure: Changes in parenchymal volume assessed by MRI
timeFrame: Baseline to up to 3 months after completion of study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Seema Khan
role: PRINCIPAL_INVESTIGATOR
References: