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

Recruiting in Palo Alto (17 mi)

Overseen by Lisa Tussing-Humphreys, PhD, MS, RD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Must not be taking: Weight loss, Anticoagulants, Antivirals, Immunosuppressants

Disqualifiers: Renal disease, Autoimmune disorders, Cancer, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 6 9 10}

Research Team

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.

Trial 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 (Behavioral Intervention)
• Time restricted eating (Behavioral Intervention)

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

Group I: Time Restricted Eating (TRE) Experimental Treatment 1 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: Control Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Time-restricted feeding (TRF) for 16 hours a day over four weeks led to a significant average weight loss of 2.6 kg in a pilot study involving 10 overweight, sedentary older adults, indicating its potential as a weight management strategy.

Participants also experienced clinically meaningful improvements in walking speed and quality of life, with high adherence rates (84%) and few reported adverse events, suggesting that TRF is a safe and feasible dietary approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. Anton, SD., Lee, SA., Donahoo, WT., et al.[2020]

Habitual continuous energy restriction (CER) has been shown to effectively prevent breast tumor formation in both animal studies and observational studies in women, while intermittent energy restriction (IER) and intermittent fasting (IF) may offer easier and potentially more effective alternatives for weight control and cancer prevention.

Animal studies suggest that IER and IF can reduce mammary tumor formation and may have different mechanisms of action compared to CER, including greater reductions in fat stores and improved insulin sensitivity, but more research is needed to directly compare these methods in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. Harvie, M., Howell, A.[2013]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Energy Restriction and Colorectal Cancer: A Call for Additional Research. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Energy restriction modulates the development of advanced preneoplastic lesions depending on the level of fat in the diet. [2013]

4. Italy pubmed.ncbi.nlm.nih.gov

Fasting/refeeding enhances the crypt multiplicity in rat colon carcinogenesis induced by azoxymethane. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of caloric restriction and dietary fat on epithelial cell proliferation in rat colon. [2013]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Time Restricted Feeding on Overweight, Older Adults: A Pilot Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. [2013]

9. England pubmed.ncbi.nlm.nih.gov

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]