Clinical trial · Interventional
Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers
Effects of Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers Among Adults With Obesity
NCT05114798CI-TRIAL-00118820active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Obesity | — | UNRESOLVED | — |
| Time Restricted Eating | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calorie Restriction | Behavioral | — | UNRESOLVED |
| Time restricted eating | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Time Restricted Eating (TRE)
- description
- 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.
- interventionNames
- Behavioral: Time restricted eating
- type
- ACTIVE_COMPARATOR
- label
- Calorie Restriction (Cal-R)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.