Active, not recruitingNot applicableInterventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age45 Years to 70 Years
SexAll
Healthy volunteersAccepted
ConditionTime Restricted Eating, Obesity, Weight Loss, Colorectal Cancer
Full registry 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)
Treatments and study arms
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
Calorie Restriction
Behavioral
daily 25% calorie restriction, 6 m active weight loss phase; 100% energy needs, 6 m maintenance phase