RecruitingNot ApplicableNCT05114798

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


Sponsor

University of Illinois at Chicago

Enrollment

255 participants

Start Date

May 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 45 YearsMax Age: 70 Years

Inclusion Criteria3

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

Exclusion Criteria17

  • 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
  • Are currently following a diet that requires fasting on a weekly basis
  • 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)

Interventions

BEHAVIORALTime restricted eating

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

BEHAVIORALCalorie Restriction

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


Locations(1)

University of Illinois at Chicago

Chicago, Illinois, United States

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NCT05114798


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