Time Restricted Diet in Obese or Overweight Pre or Postmenopausal Participants

NCT02154984 | Terminated DMC

• 4 other identifiers: NU 13CC12NCI-2014-01094STU00091568P30CA060553
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, no Evidence of Disease; Obesity

Outcome Measures

Primary Outcomes (2)

• Adherence to self-monitoring

  Assessed by demonstrating that at least 65% of participants record dietary intake on at least 80% of study intervention days. Adherence will be assessed via a one-sample chi-squared test for proportions.

  Up to 3 months after completion of study

• Attaining the goal of dietary time restriction

  Assessed by demonstrating that at least 65% of participants recorded appropriate time restriction on at least 80% of study days.

  Up to 3 months after completion of study

Secondary Outcomes (9)

• Changes in steroid hormones (estradiol, progesterone, testosterone) levels

  Baseline to up to 3 months after completion of study

• Changes in gonadotropins (FSH) levels

  Baseline to up to 3 months after completion of study

• Changes in insulin axis (insulin, insulin-like growth factor 1, IGF binding protein 3, homeostatic model assessment, homocystein) levels

  Baseline to up to 3 months after completion of study

• Changes in adipokines (leptin, adiponectin, low molecular weight adiponectin) levels

  Baseline to up to 3 months after completion of study

• Changes in inflammatory axis (interleukin-6, tumor necrosis factor alpha) levels

  Baseline to up to 3 months after completion of study

Study Arms (1)

Behavioral (time restricted diet)

EXPERIMENTAL

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.

Behavioral: behavioral dietary intervention; Behavioral: telephone-based intervention; Other: laboratory biomarker analysis

Interventions

behavioral dietary intervention BEHAVIORAL

Follow tRD

Behavioral (time restricted diet)

telephone-based intervention BEHAVIORAL

Receive coaching calls

Behavioral (time restricted diet)

laboratory biomarker analysis OTHER

Correlative studies

Behavioral (time restricted diet)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Avon Foundation Center of Excellence: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seema Khan

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: July 1, 2014
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

US (1)