255 Participants Needed

Time-Restricted Eating vs. Calorie Restriction for Weight Loss and Colorectal Cancer Risk Reduction

LT
KV
Overseen ByKrista Varady, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking weight loss medications, anticoagulant medications, medications with endoscopic risk, antivirals, and immunosuppressant medications.

What data supports the effectiveness of the treatment Time-Restricted Eating vs. Calorie Restriction for Weight Loss and Colorectal Cancer Risk Reduction?

Research shows that time-restricted eating (TRE) can lead to 3% to 5% weight loss and reduce oxidative stress and insulin resistance in humans, which are factors linked to obesity and cancer risk. Additionally, caloric restriction (CR) has been shown to extend lifespan and delay age-related diseases, including cancer, suggesting potential benefits for colorectal cancer prevention.12345

Is time-restricted eating or calorie restriction safe for humans?

Time-restricted eating (TRE) and calorie restriction (CR) are generally safe for humans. Studies show that TRE is safe and acceptable among adults with obesity, leading to weight loss and improvements in health markers without significant adverse events. Similarly, energy restriction strategies, including intermittent fasting, have shown safety and potential health benefits, though further research is needed to fully understand their effects.12678

How does the treatment of time-restricted eating and calorie restriction differ from other treatments for weight loss and colorectal cancer risk reduction?

Time-restricted eating (TRE) and calorie restriction (CR) are unique because they focus on when and how much you eat, rather than what you eat. TRE involves eating within a specific time window each day, which can naturally reduce calorie intake and has shown potential cancer-protective effects in animals. Unlike traditional diets, these methods may improve adherence and offer additional health benefits like reduced oxidative stress and insulin resistance.126910

What is the purpose of this trial?

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.

Research Team

LT

Lisa Tussing-Humphreys, PhD, MS, RD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for adults aged 45-65 with obesity (BMI 30-49.99) who are prediabetic or insulin resistant, and those at elevated risk for colorectal cancer due to recent polyps. Participants must be up to date with CRC screening and not on any weight loss program, drug abuse, or have a history of certain diseases like renal disease or cancer treatment within the last year.

Inclusion Criteria

I am between 45 and 70 years old.
BMI 30-49.99 kg/m2
Are up to date with CRC screening

Exclusion Criteria

I have a history of serious health issues like kidney disease, autoimmune disorders, or severe heart and lung conditions.
I have been treated for cancer or have a genetic risk for colorectal cancer in the last year.
I am not on any weight loss medications.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three groups: time-restricted eating, calorie restriction, or control, and undergo a 6-month intervention period.

6 months
Weekly visits for intervention adherence review

Maintenance

Participants maintain weight loss and continue monitoring for an additional 6 months.

6 months
Visits every 3 months for outcome measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Calorie Restriction
  • Time restricted eating
Trial Overview The study compares two weight loss methods: daily calorie restriction versus time-restricted eating (a form of intermittent fasting), to see which is more effective in reducing body weight and lowering the risk markers for colorectal cancer in obese individuals.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Time Restricted Eating (TRE)Experimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Controls will be instructed to maintain their weight throughout the 12 m trial and to not change eating or physical activity habits. Controls will not receive dietary counseling. Controls will visit the research center every 3 months for outcome measurements.
Group III: Calorie Restriction (Cal-R)Active Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

A 12-month randomized controlled trial will investigate the effects of time-restricted eating (TRE) and daily calorie restriction (Cal-R) on obesity and colorectal cancer (CRC) risk in 255 adults at increased risk for CRC.
Preliminary evidence suggests that TRE is safe and can lead to a weight loss of about 3% to 5%, along with improvements in metabolic health, but its specific effects on CRC prevention have not been rigorously tested before this study.
The basis and design for time-restricted eating compared with daily calorie restriction for weight loss and colorectal cancer risk reduction trial (TRE-CRC trial).Gabel, K., Fitzgibbon, ML., Yazici, C., et al.[2023]
Caloric restriction and various forms of energy restriction, like intermittent fasting, have shown promising anti-cancer properties and may help prevent and treat colorectal cancer, which has a high mortality rate.
While energy restriction strategies appear beneficial, further research is needed to understand the optimal conditions for their effectiveness and safety in cancer treatment, particularly regarding diet composition and fasting duration.
Energy Restriction and Colorectal Cancer: A Call for Additional Research.Castejón, M., Plaza, A., Martinez-Romero, J., et al.[2020]
Energy restriction (ER) significantly reduced the total number of aberrant crypt foci (ACF) in male Fischer 344 rats, regardless of whether they were on a high-fat or low-fat diet, indicating a potential protective effect against colonic lesions.
The low-fat energy-restricted (LFER) diet was particularly effective, leading to fewer advanced ACF and tumors compared to the high-fat energy-restricted (HFER) diet, suggesting that dietary fat content plays a crucial role in modulating tumor development.
Energy restriction modulates the development of advanced preneoplastic lesions depending on the level of fat in the diet.Lasko, CM., Good, CK., Adam, J., et al.[2013]

References

The basis and design for time-restricted eating compared with daily calorie restriction for weight loss and colorectal cancer risk reduction trial (TRE-CRC trial). [2023]
Energy Restriction and Colorectal Cancer: A Call for Additional Research. [2020]
Energy restriction modulates the development of advanced preneoplastic lesions depending on the level of fat in the diet. [2013]
Fasting/refeeding enhances the crypt multiplicity in rat colon carcinogenesis induced by azoxymethane. [2013]
Effects of caloric restriction and dietary fat on epithelial cell proliferation in rat colon. [2013]
Safety of 8-h time restricted feeding in adults with obesity. [2019]
The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. [2020]
Energy restriction and the prevention of breast cancer. [2013]
Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Calorie Restriction for Cancer Prevention and Therapy: Mechanisms, Expectations, and Efficacy. [2022]
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