Time Restricted Eating for Cancer Prevention

(FIBER+TRE Trial)

Overseen By Ashlea Braun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Inflammatory bowel disease, Food allergies, Eating disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different eating plans might reduce cancer risk. Participants will try time-restricted eating (eating within a set window each day), increasing dietary fiber, or a combination of both. It is ideal for adults with a body mass index (BMI) of 30 or higher who consume 15 grams or less of fiber daily. Participants need a compatible cell phone for tracking purposes.

As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research on how diet impacts cancer risk.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using GLP-1 receptor agonists (a type of medication often used for diabetes and weight management).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both dietary fiber and time-restricted eating (TRE) are safe for people. Studies have found that increasing dietary fiber is generally safe and can help protect against various types of cancer by influencing how the body processes food.

Time-restricted eating has also undergone study, revealing no serious side effects. It seems to be a safe method for managing eating habits and might improve overall health, including reducing cancer risk. Most people can easily adapt to these dietary changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a natural and lifestyle-based approach to cancer prevention. Time Restricted Eating (TRE) is unique because it involves limiting daily eating to a specific window of time, potentially improving metabolism and reducing cancer risk without the need for medication. Dietary Fiber, on the other hand, is known to enhance digestive health and may lower cancer risk by improving gut health and reducing inflammation. Unlike traditional cancer prevention methods that might involve medications or supplements, these treatments focus on simple dietary adjustments that can be easily incorporated into daily life.

What evidence suggests that this trial's treatments could be effective for cancer prevention?

Research has shown that eating within a specific time window each day, known as time-restricted eating (TRE), can improve how the body processes food, potentially lowering the risk of cancers linked to obesity. Short-term studies have found that TRE can enhance health and quality of life, with many individuals adhering to it. In this trial, some participants will follow a TRE regimen, while others will focus on increasing dietary fiber intake. Increased fiber consumption has been associated with a lower risk of certain cancers, such as colon and prostate cancers, and is linked to longer, healthier lives. Additionally, one group in this trial will combine TRE with increased fiber intake, which might reduce cancer risk by enhancing overall health and bodily function. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 30 or higher, who are at least 18 years old and consume less than 15 grams of dietary fiber per day. Participants must have a compatible cell phone to use the required app. It's not for those with food allergies that affect diet, pregnant or breastfeeding women, individuals planning pregnancy, people with conditions limiting fiber intake, or users of GLP-1 receptor agonists.

Inclusion Criteria

Body mass index ≥30 kg/m2

I am 18 years old or older.

Dietary fiber intake ≤15 g/day

Exclusion Criteria

Food allergies or intolerances that limit ability to engage with the intervention

Currently pregnant or breastfeeding, or planning to become pregnant

I have a condition that prevents me from eating fiber.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo dietary interventions involving Time Restricted Eating (TRE) and/or Fiber intake

3 months

Regular monitoring through diet records and physical activity tracking

Observation

Participants are observed for long-term effects of the dietary interventions

9 months

Periodic assessments including blood samples and physical measurements

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Fiber and Time Restricted Eating

Trial Overview The study investigates how two dietary approaches—time-restricted eating and increased dietary fiber—affect cancer risk. Participants will receive counseling and group education to help them adhere to these eating patterns.

How Is the Trial Designed?

Group I: Time Restricted Eating (TRE) Experimental Treatment 1 Intervention

Group II: Fiber for Improvement of Behavior, Eating, and Risk (FIBER) Experimental Treatment 2 Interventions

Group III: FIBER and TRE Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12509222/

Dietary fiber consumption and outcomes of different cancers Conclusions. Higher dietary fiber intake is linked to reduced cancer risk and improved outcomes. These findings highlight dietary fiber's ...

2. mdpi.com mdpi.com/2072-6643/15/11/2545

Use of Dietary Fibers in Reducing the Risk of Several ... The results of subgroup analysis showed that both soluble and insoluble dietary fiber were protective against prostate cancer (RR = 0.78; 95% CI ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561423003631

Dietary fiber intake and all-cause and cause-specific mortality Random-effect meta-analysis shows that higher consumption of total dietary fiber, significantly decreased the risk of all-cause mortality, CVD-related mortality ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1510564/epub

Dietary fiber influence on overall health, with an emphasis ... Research has shown that increasing fiber intake can reduce the risk of various chronic diseases, such as cardiovascular diseases (CVD), type II ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6112064/

The Benefits of Dietary Fiber Intake on Reducing the Risk ... This review suggests that those consuming the highest amounts of dietary fiber may benefit from a reduction in the incidence of developing colorectal cancer.

6. patlynk.com patlynk.com/trial/NCT07219706

Dietary Fiber and Time Restricted Eating on Cancer Risk This study focuses on understanding how two specific dietary changes might influence the risk of developing cancer. It looks at the effects of increasing ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523137130

Dietary fiber intake and risk of colorectal cancer ... Increased fiber intake may lead to a dilution of fecal carcinogens, reduced transit time, and bacterial fermentation of fiber to short-chain fatty acids with ...

8. nature.com nature.com/articles/s41467-022-28662-5

Randomized controlled trial for time-restricted eating in ... Furthermore, no serious side-effects have been documented during previous studies of TRF in humans. Previous studies have shown that the effects ...

9. mdpi.com mdpi.com/2072-6643/13/10/3476

Time-Restricted Eating: A Novel and Simple Dietary ... We describe the feasibility and safety of TRE and the available evidence for the impact of TRE on metabolic, cardiovascular, and cancer-specific health benefits ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10255454/

Use of Dietary Fibers in Reducing the Risk of Several ... The study provides strong evidence for the protective effects of dietary fiber on most cancers, indicating that increasing the intake of dietary ...