Time Restricted Eating on Cancer Risk

NCT05038137 | Completed Results

• 1 other identifier: 109489
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Time Restricted Feeding; Pre-diabetes

Outcome Measures

Primary Outcomes (3)

• Change in Advanced Glycation End Products (AGE) as Assessed by Plasma

  Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.

  Visit 1 (0 weeks), Visit 2 (14 weeks)

• Change in sRAGE(Soluble Receptor for AGE) Levels

  Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups.

  Visit 1 (0 weeks), Visit 2 (14 weeks)

• Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.

  Percentage of dietary visits that participant reported compliance with randomized eating period.

  Visit 1 (0 weeks), Visit 2 (14 weeks)

Secondary Outcomes (10)

• Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels

  Visit 1 (0 weeks), Visit 2 (14 weeks)

• Change in Fasting Insulin Levels

  Visit 1 (0 weeks), Visit 2 (14 weeks)

• Difference in Glasgow Prognostic Scoring System

  Visit 1 (0 weeks), Visit 2 (14 weeks)

• Change in 24 Hour Urinary AGE Levels

  Visit 1 (0 weeks), Visit 2 (14 weeks)

• Adherence to Virtual Visit With Psychologist or Dietician

  Visit 1 (0 weeks), Visit 2 (14 weeks)

Study Arms (2)

Time restricted feeding

EXPERIMENTAL

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

Behavioral: Time restricted feeding

Control

ACTIVE COMPARATOR

daily eating period ≥ 12 hours for 12 weeks

Behavioral: Control

Interventions

Control BEHAVIORAL

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

Control

Time restricted feeding BEHAVIORAL

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

Time restricted feeding

Eligibility Criteria

• Age: 40 Years - 67 Years
• Gender Eligibility Details: 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).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Breast Neoplasms; Intermittent Fasting

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fasting; Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Karanchi
• Organization: Medical University of South Carolina

karanchi@musc.edu

(843) 792-2529

Study Officials

• Harsha Karanchi, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

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

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: May 4, 2022
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: January 9, 2026
• Results First Posted: July 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)