Comparing time-restricted eating and continuous calorie restriction for weight loss and colorectal cancer risk
Effects of Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers Among Adults With Obesity
This study is testing if eating all your meals in a specific time window can help obese adults lose weight and lower their risk of colorectal cancer compared to eating fewer calories throughout the day.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 255 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05114798 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of time-restricted eating, a form of intermittent fasting, compared to daily continuous calorie restriction in helping obese individuals lose weight and reduce their risk of colorectal cancer. The study targets adults aged 45-70 with a BMI between 30 and 49.99 kg/m2, who are up to date with colorectal cancer screening. Participants will consume all their daily calories within a specified time frame while fasting for the remaining hours. Previous pilot studies have indicated that this approach is safe and may lead to significant weight loss and improvements in health markers associated with cancer risk.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 45-70 with obesity (BMI 30-49.99 kg/m2) who are compliant with colorectal cancer screening guidelines.
Not a fit: Patients with a history of certain medical conditions, recent cancer treatment, or those currently on a weight loss diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective method for obese individuals to manage their weight and lower their colorectal cancer risk.
How similar studies have performed: Previous pilot studies have shown promise for time-restricted eating as an effective intervention for weight loss and health improvement, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 45-70 years old, 2. BMI 30-49.99 kg/m2 3. Are up to date with CRC screening. Exclusion Criteria: 1. 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; 2. Abuse alcohol (\> 50 grams/day), illicit drugs (other than self-reported marijuana use), or use combustible tobacco; 3. Have controlled type 2 diabetes or undiagnosed uncontrolled diabetes based on hemoglobin A1c (HbA1c) \> 9.0%; 4. Have a history of cancer treatment within the past 12 months, CRC, genetic predisposition to CRC (e.g., Lynch syndrome); 5. Have a baseline body weight \> 450 lbs (weight limitation of the DXA); 6. Are on a weight loss diet or actively involved in a formal weight loss program (e.g., Weight Watchers); 7. Are not weight stable for 3 months prior to the study (weight gain or loss \> 4 kg); 8. Are unable to keep a food diary for 7 consecutive days during screening; 9. Are night shift workers; 10. Are pregnant or trying to get pregnant; 11. Are taking drugs that influence study outcomes (weight loss medications); 12. Are non-English speaking 13. Are taking anticoagulant medications or medications with endoscopic risk 14. Are taking antivirals or immunosuppressant medications 15. Don't have regular access to an email address and computer/smartphone/tablet 16. Are currently following a diet that requires fasting on a weekly basis 17. Currently eat for less than 10 hours of the day (determined by asking participants what time they start and stop eating on a usual day)
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Tussing-Humphreys, PhD, MS, RD — University of Illinois at Chicago
- Study coordinator: Lisa Tussing-Humphreys, PhD, MS, RD
- Email: tussing@uic.edu
- Phone: 312-355-5521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.