Time Restricted Eating + Prebiotic for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Kelsey Gabel, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Must not be taking: Glucoregulatory medications

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

No Placebo Group

Trial Summary

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.

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}

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

Trial 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 (Behavioural Intervention)
• Time Restricted Eating (Behavioural Intervention)
• Time restricted eating + prebiotic (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Illinois at Chicago Chicago, IL

Who Is Running the Clinical Trial?

University of Illinois at Chicago Lead Sponsor

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] The soaring prevalence of obesity and its complications presents a significant health care burden, and there is currently a lack of effective and sustainable treatment methods. Time-restricted eating (TRE) is a specific intermittent fasting (IF) protocol involving consistent fasting and eating periods within a 24-hour cycle. Time-restricted eating can restore robust circadian rhythms and improve metabolic health, providing an emerging dietary strategy for the prevention and treatment of obesity and related metabolic diseases. Previous TRE trials laid the groundwork, and indicate a need for further clinical research including large-scale controlled trials to determine TRE efficacy and the mechanisms by which it may affect humans.

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] Circadian disruption-induced metabolic syndrome (CDIMS) involves body weight gain, changes in blood profile and gut microbiota. In this study, CDIMS was induced by shifted light dark cycle (SLDC) in C57BL/6J mice. Dietary intervention by oral administration of oat β-glucan (a polymeric prebiotic) alleviated CDIMS when compared to chicory inulin/fructan (an oligomeric prebiotic) and melatonin (a chronobiotic). Oat β-glucan reversed the increase in body weight, liver weight-to-body weight ratio and plasma leptin concentration as well as restored glucose tolerance. In altering gut microbiota, oat β-glucan increased the species richness, reversed the populations of 7 bacterial genera and increased butyrate producers including Ruminococcaceae and Lachnospiraceae which enhance gut barrier protection and regulate glucose homeostasis. Correlation analysis demonstrated the linking of the alleviation of CDIMS by prebiotics and melatonin with different microbial metabolic pathways involved in energy metabolism, biosynthesis of metabolites, metabolism of cofactors and vitamins and endocrine synthesis.

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] Time-restricted feeding (TRF) confers protection against nutritional challenges that predispose obesity and metabolic risks through involvement of circadian locomotor output cycles protein kaput genes and gut microbiome, but the underlying mechanism is not clearly understood. Therefore, the present study examined the effects of TRF on metabolic markers and circadian rhythm associated with gut microbiota in healthy males. Two groups (TRF, n 56; non-TRF, n 24) of male adults were enrolled. The TRF group provided blood at pre-TRF and post-TRF, while non-TRF one time after 25 d of trial. Serum lipid and liver profiles were determined. Real time-PCR was applied for circadian and inflammatory gene expression. The 16S rRNA genes were sequenced on the Illumina Miseq v3 platform to comprehensively catalogue the composition and abundance of bacteria in stool. We showed that TRF ameliorated the serum lipid and liver profiles of the individuals. In the TRF group, gut microbial richness was significantly enhanced, with enrichment of Prevotellaceae and Bacteroideaceae. TRF enhanced circadian gene expression probably by activation of sirtuin-1, which is positively associated with gut microbiome richness. TRF could be a safe remedy for the prevention of metabolic diseases related to dyslipidaemia, as it regulates circadian rhythm associated with gut microbiome modulation.

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

Brain-Gut-Microbiome Interactions and Intermittent Fasting in Obesity. [2022] The obesity epidemic and its metabolic consequences are a major public health problem both in the USA and globally. While the underlying causes are multifactorial, dysregulations within the brain-gut-microbiome (BGM) system play a central role. Normal eating behavior is coordinated by the tightly regulated balance between intestinal, extraintestinal and central homeostatic and hedonic mechanisms, resulting in stable body weight. The ubiquitous availability and marketing of inexpensive, highly palatable and calorie-dense food has played a crucial role in shifting this balance towards hedonic eating through both central (disruptions in dopaminergic signaling) and intestinal (vagal afferent function, metabolic toxemia, systemic immune activation, changes to gut microbiome and metabolome) mechanisms. The balance between homeostatic and hedonic eating behaviors is not only influenced by the amount and composition of the diet, but also by the timing and rhythmicity of food ingestion. Circadian rhythmicity affects both eating behavior and multiple gut functions, as well as the composition and interactions of the microbiome with the gut. Profound preclinical effects of intermittent fasting and time restricted eating on the gut microbiome and on host metabolism, mostly demonstrated in animal models and in a limited number of controlled human trials, have been reported. In this Review, we will discuss the effects of time-restricted eating on the BGM and review the promising effects of this eating pattern in obesity treatment.

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] Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.

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

Identification of factors influencing motivation to undertake time-restricted feeding in humans. [2021] The interaction between time of day and energy intake, termed chrono-nutrition, has received considerable recent interest. One aspect of chrono-nutrition with potential to benefit long-term cardio-metabolic health is time-restricted feeding (TRF). Current support for TRF primarily derives from animal research, although recent small-scale human studies indicate possible translational benefit. Whether free-living humans, however, can incorporate TRF into their daily lives is poorly understood. This study reports data from participants (n = 608) who completed an online questionnaire to investigate daily routine, likelihood of TRF incorporation within work vs free-days, and key considerations influencing TRF uptake. The majority of participants reported a typical daily feeding window (time between first and last energy intake) of between 10 and 14 h on workdays and free days, 62.7 and 65.5% respectively. Likelihood of adherence to TRF declined with an increase in the proposed restriction of the feeding window by 0.5 to 4-h per day. We then examined data from participants with a typical daily feeding window of 12+ h on workdays (n = 221) and free-days (n = 223) to investigate the likelihood of using TRF, and the most important considerations in making this decision. Of these participants, (n = 132) on workdays and (n = 125) on free days would likely reduce their feeding window by 3-h. Multiple regression analysis revealed that key considerations determining the likelihood of adopting TRF were: cost, time availability, and perceived health benefits (on workdays); wake time, bed time, time availability, motivation to change and perceived health benefits (on free-days). These data provide novel information regarding public attitudes towards TRF and highlight important aspects to be considered when translating controlled laboratory studies to public dietary advice.

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

Complex physiology and clinical implications of time-restricted eating. [2023] Time-restricted eating (TRE) is a dietary intervention that limits food consumption to a specific time window each day. The effect of TRE on body weight and physiological functions has been extensively studied in rodent models, which have shown considerable therapeutic effects of TRE and important interactions among time of eating, circadian biology, and metabolic homeostasis. In contrast, it is difficult to make firm conclusions regarding the effect of TRE in people because of the heterogeneity in results, TRE regimens, and study populations. In this review, we 1) provide a background of the history of meal consumption in people and the normal physiology of eating and fasting; 2) discuss the interaction between circadian molecular metabolism and TRE; 3) integrate the results of preclinical and clinical studies that evaluated the effects of TRE on body weight and physiological functions; 4) summarize other time-related dietary interventions that have been studied in people; and 4) identify current gaps in knowledge and provide a framework for future research directions.

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

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022] Time restricted feeding is a form of intermittent fasting where participants shorten the daily window in which they eat.

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] Lengthening the daily eating period contributes to the onset of obesity and metabolic syndrome. Dietary approaches, including energy restriction and time-restricted feeding, are promising methods to combat metabolic disorders. This study explored the effect of early and late time-restricted feeding (TRF) on weight and adiposity, food consumption, glycemic control, clock gene expression, and liver metabolite composition in diurnal Nile grass rats (NGRs). Adult male and female Nile grass rats were randomly assigned to one of three groups: (1) access to a 60% high-fat (HF) diet ad-libitum (HF-AD), (2) time-restricted access to the HF diet for the first 6 h of the 12 h light/active phase (HF-AM) or (3) the second 6 h of the 12 h light/active phase (HF-PM). Animals remained on their respective protocols for six weeks. TRF reduced total energy consumption and weight gain, and early TRF (HF-AM) reduced fasting blood glucose, restored Per1 expression, and reduced liver lipid levels. Although sex-dependent differences were observed for fat storage and lipid composition, TRF improved metabolic parameters in both male and female NGRs. In conclusion, this study demonstrated that early TRF protocol benefits weight management, improves lipid and glycemic control, and restores clock gene expression in NGRs.

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] To design an appealing time-restricted eating (TRE) intervention by exploring behavioral and social mechanisms to improve TRE adoption and maintenance among people with type 2 diabetes (T2D) and overweight. Time-restricted eating is an intermittent fasting regimen suggested to improve glycemic control and body weight.