Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants

NCT ID: NCT02154984

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-02-23

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.

Conditions

Healthy, no Evidence of Disease; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Behavioral (time restricted diet)

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.

Group Type: EXPERIMENTAL

behavioral dietary intervention

Intervention Type: BEHAVIORAL

Follow tRD

telephone-based intervention

Intervention Type: BEHAVIORAL

Receive coaching calls

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

behavioral dietary intervention

Follow tRD

Intervention Type: BEHAVIORAL

telephone-based intervention

Receive coaching calls

Intervention Type: BEHAVIORAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Avon Foundation Center of Excellence

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seema Khan

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2014-01094

Identifier Type: REGISTRY

Identifier Source: secondary_id

STU00091568

Identifier Type: -

Identifier Source: secondary_id

NU 13CC12

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA060553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NU 13CC12

Identifier Type: -

Identifier Source: org_study_id