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

30 Participants Needed

Trial Summary

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).

What data supports the effectiveness of the treatment Time Restricted Eating + Prebiotic for Obesity?

Research shows that time-restricted eating (TRE) can help improve metabolic health and support weight loss by restoring circadian rhythms and reducing calorie intake. Additionally, prebiotics like oat β-glucan have been shown to improve gut health and metabolic markers, suggesting that combining TRE with prebiotics could be an effective strategy for managing obesity. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) appears to be generally safe for humans, as studies have shown it can improve metabolic health markers like insulin resistance and lipid profiles without significant adverse effects. It also enhances gut microbiome richness, which is associated with better health outcomes. ^{3 5 6 7 8}

How is the treatment of Time Restricted Eating + Prebiotic for Obesity different from other treatments?

This treatment is unique because it combines time-restricted eating, which involves eating only during a specific window each day, with prebiotics that support gut health. This approach not only helps manage weight by reducing calorie intake but also improves metabolic health and circadian rhythms, potentially offering a more holistic way to address obesity compared to traditional methods. ^{1 3 8 9 10}

What is the purpose of this trial?

This study aims to address a critical gap in pediatric oncology survivorship care by exploring innovative solutions to addressing obesity and its comorbidities in pediatric cancer survivors. The majority (99%) of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition. Obesity, cardiovascular, and metabolic diseases are the most common treatment-related late effects among pediatric cancer survivors. Improving diet and reducing obesity has the potential to dramatically improve the quality of life and long-term health of pediatric cancer survivors. Utilization of a prebiotic fiber supplement along with TRE amy improve the gut microbiome, short-chain fatty acid synthesis, and hunger hormones to further improve weight loss with TRE and a greater decrease in cardiometabolic risk. The aims of this study are to test the safety, feasibility, and acceptability of 8-h TRE or 8-h TRE with a fiber supplement among young adult (YA) pediatric cancer survivors. The investigators further strive to examine the preliminary efficacy of TRE on body weight, body composition, glucose regulation, and cardiovascular risk markers. Data obtained will be used to inform a larger efficacy trial of TRE among adolescent and young adult pediatric cancer survivors. Given that a majority of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition exploring accessible nutritional strategies to improve long term health trajectory of 70,000+ AYA diagnosed with cancer each year in the United States. This study of TRE will provide important preliminary evidence of the benefits of this nutrition therapy for YA pediatric cancer survivors. The long-term goal of this line of inquiry is to improve both short and long-term outcomes for YA pediatric cancer survivors.

Research Team

Kelsey Gabel, PhD

Principal Investigator

UIC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Research progress on the application of time-restricted eating in adult obesity and related metabolic diseases]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Circadian disruption-induced metabolic syndrome in mice is ameliorated by oat β-glucan mediated by gut microbiota. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of time-restricted feeding on metabolic risk and circadian rhythm associated with gut microbiome in healthy males. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Brain-Gut-Microbiome Interactions and Intermittent Fasting in Obesity. [2022]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Identification of factors influencing motivation to undertake time-restricted feeding in humans. [2021]

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

Complex physiology and clinical implications of time-restricted eating. [2023]

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

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Early Time-Restricted Feeding Amends Circadian Clock Function and Improves Metabolic Health in Male and Female Nile Grass Rats. [2022]

10. United States 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. [2023]