Time Restricted Eating on Cancer Risk

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-04

Study Completion Date

2024-04-23

Brief Summary

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Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.

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Detailed Description

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Conditions

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Time Restricted Feeding Pre-diabetes Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Visit 1 at 0 weeks, followed by 2 week run-in and then randomization. Visit 2 at 14 weeks.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Time restricted feeding

daily eating period of 8 hours, before 8 PM for 12 weeks

Group Type EXPERIMENTAL

Time restricted feeding

Intervention Type BEHAVIORAL

Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.

Control

daily eating period ≥ 12 hours for 12 weeks

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Participants will have a daily eating period equal to or greater than 12 hours.

Interventions

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Time restricted feeding

Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.

Intervention Type BEHAVIORAL

Control

Participants will have a daily eating period equal to or greater than 12 hours.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 40 and ≤ 67;
* Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing;
* Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;

Exclusion Criteria

* Tobacco use (current or within last 2 years);
* Active malignancy or history of cancer;
* History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase ≥ 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history);
* History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²);
* History of diabetes mellitus:
* History of cardiovascular disease (MI, CHF);
* Current prescription medication use for diabetes;
* Medication affecting glucose metabolism or appetite or immunosuppression;
* Dietary restrictions: currently following vegetarian or vegan dietary pattern;
* Currently following intermittent fasting or time restricted feeding pattern or use in the last 3 months;
* Night shift worker (work schedule does not involve any period of work from 10 PM to 5 AM either on a regular or rotating basis);
* History of weight loss \>5% in the last 3 months;
* History of weight loss surgery.
* BMI≥40 kg/m² exclusion;
* After informed consent and run in period: Insufficient documented food photography/annotated entries (does not log at least two entries a day for 10 of 14 days) during run in period will be excluded from randomization in to the intervention period.

Minimum Eligible Age

40 Years

Maximum Eligible Age

67 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No