Actively Recruiting

Phase Not Applicable
Age: 45Years - 70Years
All Genders
Healthy Volunteers
NCT05114798

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

Led by University of Illinois at Chicago · Updated on 2025-07-09

255

Participants Needed

1

Research Sites

276 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 45 to 70 years old
  • Body mass index (BMI) between 30 and 49.99 kg/m2
  • Up to date with colorectal cancer screening
Not Eligible

You will not qualify if you...

  • History of renal disease, autoimmune disorders, immunodeficiency, malabsorptive disorder, significant gastrointestinal or liver disease, gastrointestinal surgery, severe ischemic heart disease, severe lung disease, severe mental health disorder, eating disorder, or bariatric surgery
  • Abuse of alcohol (more than 50 grams/day), illicit drugs (except self-reported marijuana use), or use of combustible tobacco
  • Have controlled type 2 diabetes or uncontrolled diabetes with hemoglobin A1c over 9.0%
  • History of cancer treatment within the past 12 months, colorectal cancer, or genetic predisposition to colorectal cancer
  • Body weight over 450 pounds (due to DXA scanner limits)
  • Currently on a weight loss diet or in a formal weight loss program
  • Not weight stable for 3 months before the study (weight change over 4 kg)
  • Unable to keep a food diary for 7 consecutive days during screening
  • Night shift workers
  • Pregnant or trying to become pregnant
  • Taking medications that impact study outcomes such as weight loss drugs
  • Non-English speaking
  • Taking anticoagulant or medications with endoscopic risk
  • Taking antiviral or immunosuppressant medications
  • Lack regular access to email and a computer, smartphone, or tablet
  • Following a diet that includes fasting weekly
  • Usually eat for less than 10 hours per day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

L

Lisa Tussing-Humphreys, PhD, MS, RD

CONTACT

K

Krista Varady, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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