Time Restricted Eating + Prebiotic for Obesity

Overseen By Kelsey Gabel, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Glucoregulatory medications

Disqualifiers: Pregnancy, Eating disorders, HIV/AIDS, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help young adult survivors of pediatric cancer manage obesity and related health issues. Researchers are testing the effectiveness of time-restricted eating (eating only between noon and 8 p.m.) with or without a prebiotic fiber supplement. The goal is to determine if these methods can improve weight, body composition, and reduce heart and blood sugar risks. The trial seeks participants who have completed cancer treatment, have a BMI between 25 and 39.99, and wish to try new weight management methods. As an unphased trial, participants can contribute to innovative research that may lead to new weight management strategies for cancer survivors.

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 on glucoregulatory medication (medications that help control blood sugar levels).

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

Research has shown that time-restricted eating (TRE) is generally easy for people to follow. Studies indicate it aids in weight loss and does not affect blood sugar levels in adults with obesity. No major safety issues have emerged, making it a safe choice for many.

Adding a prebiotic to TRE also appears safe. One study found that combining time-restricted eating with a prebiotic led to significant weight loss without any reported side effects. This combination improved insulin and blood sugar levels, particularly in overweight individuals.

Overall, both TRE and TRE with prebiotics have been studied for their effects on weight and metabolism, with no significant safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obesity because they explore innovative approaches beyond traditional dieting and exercise. Time Restricted Eating (TRE) focuses on limiting food intake to an 8-hour window, which may help regulate metabolism and reduce calorie consumption naturally. The combination of TRE with a prebiotic supplement is particularly intriguing as prebiotics can enhance gut health, potentially boosting metabolism and promoting weight loss. Unlike standard treatments that often involve medication or more restrictive dieting, these methods aim to harness natural body rhythms and gut health, offering a potentially sustainable way to manage obesity.

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

This trial will compare time-restricted eating (TRE) alone with TRE combined with a prebiotic supplement. Research has shown that TRE can help people lose weight and improve body mass index and fat levels. Studies have found that those who follow TRE often lose between 1% to 4% of their body weight. TRE can also reduce waist size and improve heart health indicators.

Combining TRE with a prebiotic supplement might also aid in weight loss and improve gut health. However, some studies suggest that adding a prebiotic does not always lead to more weight loss than TRE alone. Overall, both TRE and its combination with a prebiotic show promise for addressing obesity and related health risks. ^{1 3 5 6 7}

Who Is on the Research Team?

Kelsey Gabel, PhD

Principal Investigator

UIC

Are You a Good Fit for This Trial?

This trial is for young adult pediatric cancer survivors aged 18-39 with a BMI of 25-39.99 kg/m2 who have completed their anti-tumor treatment. It's not for those with diabetes, severe obesity or underweight, pregnant or breastfeeding women, night shift workers, individuals with certain medical conditions that prevent informed consent or participation in the trial.

Inclusion Criteria

Able to provide (self or guardian) written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization

BMI 25-39.99 kg/m2

I understand and can follow the study's procedures.

Exclusion Criteria

Individual does not have access to the Internet

I have a history of heart issues, stroke, or chronic liver/pancreas conditions.

Individuals with a history of eating disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Time Restricted Eating (TRE) with or without a prebiotic fiber supplement for weight management

12 weeks

Weekly visits for weight and body composition assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Time Restricted Eating
• Time restricted eating + prebiotic

Trial Overview The study tests time-restricted eating (TRE) alone and TRE combined with a prebiotic fiber supplement to manage weight and improve health outcomes like body composition and cardiovascular risk markers in pediatric cancer survivors.

How Is the Trial Designed?

Group I: Time restricted eating Experimental Treatment 1 Intervention

Individuals will eat between 12-8pm ad libitum, fasting from 8-12pm.

Group II: TRE+ prebiotic supplement Experimental Treatment 1 Intervention

Individuals will eat between 12-8pm ad libitum, fasting from 8-12pn with the addition of a prebiotic fiber supplement with the first eating bout of the day.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

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]

In a study on C57BL/6J mice, oat β-glucan was found to effectively alleviate symptoms of circadian disruption-induced metabolic syndrome (CDIMS), reversing weight gain and improving glucose tolerance compared to other treatments like chicory inulin and melatonin.

Oat β-glucan also positively altered gut microbiota by increasing species richness and promoting beneficial bacteria, which are linked to improved gut health and metabolic regulation, highlighting its potential as a dietary intervention for metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian disruption-induced metabolic syndrome in mice is ameliorated by oat β-glucan mediated by gut microbiota. Cheng, WY., Lam, KL., Li, X., et al.[2023]

The obesity epidemic is significantly influenced by disruptions in the brain-gut-microbiome (BGM) system, which affects eating behaviors and body weight regulation due to factors like the availability of calorie-dense foods and changes in gut microbiome composition.

Time-restricted eating shows promising effects on the gut microbiome and host metabolism, suggesting it could be an effective strategy for obesity treatment, as indicated by preclinical studies and some controlled human trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Gut-Microbiome Interactions and Intermittent Fasting in Obesity. Frank, J., Gupta, A., Osadchiy, V., et al.[2022]

Time-restricted eating (TRE) is a promising dietary strategy that can help improve metabolic health and restore circadian rhythms, potentially aiding in the prevention and treatment of obesity and its complications.

Current evidence from previous TRE trials suggests a need for more extensive clinical research, including large-scale controlled trials, to fully understand the efficacy and mechanisms of TRE in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. He, JH., Sun, CY., Liang, C.[2022]

Time-restricted feeding (TRF) improved serum lipid and liver profiles in healthy males, suggesting it may help prevent metabolic diseases related to dyslipidaemia.

TRF enhanced gut microbiome richness and circadian gene expression, likely through the activation of sirtuin-1, indicating a mechanism by which TRF supports metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time-restricted feeding on metabolic risk and circadian rhythm associated with gut microbiome in healthy males. Zeb, F., Wu, X., Chen, L., et al.[2021]

Early time-restricted feeding (TRF) significantly reduced weight gain and total energy consumption in Nile grass rats, suggesting it may be an effective strategy for weight management.

The early TRF protocol improved glycemic control by lowering fasting blood glucose levels and restored the expression of the clock gene Per1, indicating potential metabolic benefits beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Time-Restricted Feeding Amends Circadian Clock Function and Improves Metabolic Health in Male and Female Nile Grass Rats. Ramanathan, C., Johnson, H., Sharma, S., et al.[2022]

In a study involving adults with obesity, both 4-hour and 6-hour time-restricted feeding (TRF) regimens led to comparable weight loss of about 3% over 8 weeks, along with improvements in insulin resistance and oxidative stress.

Participants in the TRF groups reduced their daily energy intake by approximately 550 kcal without needing to count calories, suggesting that TRF can be an effective and manageable approach for weight loss and improving cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2022]

A study involving 608 participants found that most people typically eat within a 10 to 14-hour window on both workdays and free days, indicating a common pattern of energy intake.

The likelihood of adopting time-restricted feeding (TRF) decreases as the proposed feeding window restriction increases, with key factors influencing this decision being cost, time availability, and perceived health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of factors influencing motivation to undertake time-restricted feeding in humans. Jefcoate, PW., Robertson, MD., Ogden, J., et al.[2021]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11221496/

Time-restricted eating: Watching the clock to treat obesity Results reveal that fasting glucose levels did not change after 2–12 months of TRE in adults with obesity, even when participants achieved 5% weight loss.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224002219

Time-restricted eating improves health because of energy ... The results showed that TRE led to modest weight loss, lower waist circumference and energy deficits. TRE also improved body mass index, fat ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2794819

Effectiveness of Early Time-Restricted Eating for Weight ... Studies have shown that TRE prevents and reverses diet-induced obesity in rodents. Adults who adhere to TRE typically lose 1% to 4% of their ...

4. nature.com nature.com/articles/s41598-025-20502-y

The effects of time-restricted feeding on early vascular, liver ... Emerging evidence suggests that TRF, which extends nighttime fasting to over 12 h, may improve key cardiovascular health indicators. In animal ...

5. mdpi.com mdpi.com/2072-6643/16/19/3390

The Effects of Time-Restricted Eating on Fat Loss in Adults ... It is observed that TRE with eating windows of 6 to 8 h, either alone or combined with caloric restriction, may be most effective for reducing body fat and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5388543/

Fasting, circadian rhythms, and time restricted feeding in ... Time-restricted feeding is a daily eating pattern in which all nutrient intake occurs within a few hours (usually ≤12h) everyday, with no overt attempt to alter ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771095

Effects of Time-Restricted Eating on Weight Loss and Other ... This randomized clinical trial examines the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers.