Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers

NCT05114798 | Recruiting DMC

• 2 other identifiers: 2020-16271R01CA257807
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 42% of American adults are obese, and this condition is strongly related to the development of colorectal cancer. Innovative lifestyle strategies to treat obesity and reduce colorectal cancer risk are critically needed. This research will demonstrate that time-restricted eating, a type of intermittent fasting, is an effective therapy to help obese individuals reduce and control their body weight and prevent the development of colorectal cancer.

Conditions

Time Restricted Eating; Obesity; Weight Loss; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Weight change (% kg)

  Body weight in kg

  Baseline to month 6

Secondary Outcomes (15)

• Total and regional body fat composition and distribution

  Baseline, 6 month and 12 month

• Intervention adherence

  Monthly, through month 6

• Fasting plasma glucose

  Baseline, month 3, month 6, month 9, month 12

• Plasma cytokines TNF-α, IL-6, IL1-β, and IL-10, %

  Baseline, month 3, month 6, month 9, month 12

• Plasma 8-isoprostane

  Baseline, month 3, month 6, month 9, month 12

Study Arms (3)

Time Restricted Eating (TRE)

EXPERIMENTAL

During the active weight loss period, the TRE group will be instructed to eat ad libitum from 12:00pm - 8:00pm daily and fast from 8:00pm - 12:00pm. During the 8-h eating window, there will be no restrictions on types or quantities of foods consumed. During the fasting period, participants will be encouraged to drink plenty of water and may consume energy-free beverages, such as black tea or coffee. TRE subjects will meet with the TRE dietitian for 30 minutes at the start of the intervention to review instructions and goals, and then every week throughout the active weight loss period to review intervention adherence. At the beginning of the maintenance phase, total energy needs will be reassessed. Subjects will be instructed to main their body weight by consuming meals in an extended 10-h eating window every day and water fast between 8pm and 10 am, respectively.

Behavioral: Time restricted eating

Calorie Restriction (Cal-R)

ACTIVE COMPARATOR

Cal-R subjects will be instructed to restrict energy intake by 25% of their baseline total energy expenditure (TEE) daily. Subjects will meet with a study dietitian for a 60-min one-on-one session to develop individualized weight loss meal plans to help them adhere to their calorie restriction goal. Meal plans will include portion sizes and food lists that are consistent with their food preferences and prescribed calorie levels for weight loss. Food scales will be provided to help with food portioning. Cal-R subjects will meet with the dietitian every week throughout the weight loss period to review intervention adherence and modify the meal plans as needed. Subjects will be asked to maintain their baseline level of physical activity. At the beginning of the weight maintenance phase, total energy needs will be reassessed.

Behavioral: Calorie Restriction

Control

NO INTERVENTION

Controls will be instructed to maintain their weight throughout the 12 m trial and to not change eating or physical activity habits. Controls will not receive dietary counseling. Controls will visit the research center every 3 months for outcome measurements.

Interventions

Time restricted eating BEHAVIORAL

daily ad libitum food intake, 8-h 12pm - 8pm, 6 m active weight loss phase; 10-h 10am-8pm, 6 m maintenance phase

Time Restricted Eating (TRE)

Calorie Restriction BEHAVIORAL

daily 25% calorie restriction, 6 m active weight loss phase; 100% energy needs, 6 m maintenance phase

Calorie Restriction (Cal-R)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,
• BMI 30-49.99 kg/m2
• Are up to date with CRC screening.

You may not qualify if:

• Have a history of renal disease, autoimmune disorders, immunodeficiency, malabsorptive disorder, significant gastrointestinal and hepatic disease, surgical change in gastrointestinal anatomy, severe ischemic heart disease, severe pulmonary disease, severe mental health disorder, eating disorder, or bariatric surgery;
• Abuse alcohol (\> 50 grams/day), illicit drugs (other than self-reported marijuana use), or use combustible tobacco;
• Have controlled type 2 diabetes or undiagnosed uncontrolled diabetes based on hemoglobin A1c (HbA1c) \> 9.0%;
• Have a history of cancer treatment within the past 12 months, CRC, genetic predisposition to CRC (e.g., Lynch syndrome);
• Have a baseline body weight \> 450 lbs (weight limitation of the DXA);
• Are on a weight loss diet or actively involved in a formal weight loss program (e.g., Weight Watchers);
• Are not weight stable for 3 months prior to the study (weight gain or loss \> 4 kg);
• Are unable to keep a food diary for 7 consecutive days during screening;
• Are night shift workers;
• Are pregnant or trying to get pregnant;
• Are taking drugs that influence study outcomes (weight loss medications);
• Are non-English speaking
• Are taking anticoagulant medications or medications with endoscopic risk
• Are taking antivirals or immunosuppressant medications
• Don't have regular access to an email address and computer/smartphone/tablet

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting; Obesity; Weight Loss; Colorectal Neoplasms

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lisa Tussing-Humphreys, PhD, MS, RD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Tussing-Humphreys, PhD, MS, RD

CONTACT

312-355-5521; tussing@uic.edu

Krista Varady, PhD

CONTACT

312-996-7897; varady@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomized by the data manager, by way of a stratified random sample in 1:1:1 ratio. The sample frame will be divided into strata based on BMI, sex, and age. Subjects from each stratum, will then be randomized to 1 of 3 groups: 1) TRE, 2) Cal-R, or 3) Control.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 10, 2021
• Study Start: May 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)