Circadian Intervention for Obesity

(TOCS Trial)

Overseen By Christopher M Depner, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Sleep aids, Glucose regulators

Disqualifiers: Sleep disorder, Diabetes, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether changing light exposure and eating habits can help individuals with overweight or obesity who typically sleep less than 6.5 hours a night. Researchers will divide participants into two groups: one will try the new circadian intervention (body clock approach), and the other will receive basic health tips. The trial is suitable for those aged 18-45 with a body mass index (BMI) of 25-34.9, who do not have major health issues and have not participated in recent weight loss programs. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle changes that may improve health and well-being.

Will I have to stop taking my current medications?

The trial excludes people using prescription drugs or substances that affect sleep or glucose metabolism, so you may need to stop taking such medications to participate.

What prior data suggests that this circadian intervention is safe for people with overweight and obesity?

Research has shown that aligning with the body's natural daily rhythms can aid in weight management. This involves reducing light exposure at night and avoiding snacks after dinner. These changes can enhance how the body processes food and controls hunger, supporting a healthy weight.

Early findings suggest that most people adapt well to this type of change. Studies have not identified any serious side effects from adjusting daily rhythms. However, while this approach may assist with weight control, results can vary among individuals.

This method does not involve medications or surgeries, often making it safer. Participants typically make lifestyle changes that can be adjusted if discomfort arises. Overall, current evidence considers this approach safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this circadian intervention for obesity because it focuses on the timing of light exposure and food intake, which is a novel approach compared to typical treatments like diet and exercise plans or medications. Unlike standard methods that primarily focus on what or how much you eat, this approach taps into the body's natural biological clock to potentially improve metabolism and weight management. By aligning lifestyle factors with circadian rhythms, this strategy offers a fresh avenue for tackling obesity, potentially enhancing the effectiveness of existing treatments.

What evidence suggests that this circadian intervention is effective for obesity?

Research shows that when the body's natural 24-hour cycle, known as circadian rhythms, is disrupted, the risk of obesity increases. These rhythms regulate energy use, metabolism, and appetite, all crucial for maintaining a healthy weight. Studies have found that eating late at night and exposure to light during nighttime can lead to weight gain and other health issues. In this trial, participants in the intervention group will receive a circadian-based intervention focused on the timing of light exposure and food intake. This method aims to improve these issues by adjusting eating and light exposure times, helping to manage weight by aligning the body's natural cycles with daily routines. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 with a BMI of 25.0-34.9 who sleep less than 6.5 hours nightly and are not currently in weight loss programs or experiencing menopause. It's not for those with significant organ diseases, diagnosed sleep disorders, psychiatric illnesses, heavy alcohol use, recent shift work history, or using drugs affecting sleep/glucose metabolism.

Inclusion Criteria

Your body mass index (BMI) is between 25.0 and 34.9.

You typically sleep less than 6.5 hours per night on average for the past 6 months.

Exclusion Criteria

You are currently participating in a weight loss or exercise program, such as the Diabetes Prevention Program.

I have a significant health condition like diabetes, heart, or kidney disease.

You drink more than 3 drinks per day or more than 14 drinks per week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 night

1 overnight visit (in-person)

Baseline

Participants undergo a ~1-week ambulatory real-world monitoring segment

1 week

1 visit (in-person) at the end of the baseline

Experimental

Participants are randomized to control or intervention groups for the 8-week segment

8 weeks

1 overnight visit (in-person) at the end of the segment

Follow-up

Participants are monitored for changes in sleep and circadian measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Circadian Intervention

Trial Overview The study tests a circadian intervention aimed at improving cardiometabolic health by reducing nighttime light exposure and after-dinner snacks versus a control group receiving basic health advice on physical activity and nutrition.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Circadian-based intervention focused on timing of light exposure and food intake.

Group II: Control Group Active Control 1 Intervention

Provided with general health information on diet and physical activity.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Circadian rhythms play a significant role in the development of obesity and metabolic diseases, as shown by studies in mice with disrupted clock genes that exhibited metabolic dysfunctions at different sleep/wake phases.

Human studies indicate that circadian desynchrony, often seen in shift workers and those with short sleep, is linked to an increased risk of obesity, highlighting the importance of maintaining regular sleep patterns for metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sleep/wake cycle, circadian disruption and the development of obesity]. Masaki, T.[2012]

Chronic desynchronization of the circadian system, such as that experienced in shift work and sleep deprivation, can promote obesity by negatively affecting energy metabolism and weight regulation.

Regular meal patterns and higher meal frequency may be more beneficial for maintaining a healthy weight compared to irregular and infrequent eating habits, although more research is needed to fully understand the impact of meal timing on weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronobiological aspects of food intake and metabolism and their relevance on energy balance and weight regulation. Ekmekcioglu, C., Touitou, Y.[2011]

Circadian clocks, which are natural 24-hour cycles in living organisms, play a crucial role in regulating metabolism and can significantly impact metabolic health, particularly in relation to obesity.

Disruptions in circadian rhythms, influenced by factors like feeding times and dietary nutrients, can lead to obesity by affecting lipid metabolism, highlighting the importance of maintaining a healthy circadian lifestyle for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian rhythms and obesity: Timekeeping governs lipid metabolism. Li, Y., Ma, J., Yao, K., et al.[2021]

Circadian rhythms play a crucial role in regulating metabolism, affecting how our bodies process energy throughout the day and night, which is important in understanding obesity.

Sleep disruptions and misalignment of our circadian rhythms are modifiable risk factors that can contribute to the development of obesity and other metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Circadian and Sleep Disruptions on Obesity Risk. Noh, J.[2020]

Circadian rhythms, regulated by clock genes, play a crucial role in coordinating metabolism, particularly in fat cells (adipocytes), and disruptions in these rhythms may contribute to metabolic syndrome and obesity.

The review discusses the potential of using chronobiology, the study of biological rhythms, as a novel approach for treating obesity, highlighting the importance of aligning lifestyle and eating patterns with the body's natural clock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronobiological aspects of obesity and metabolic syndrome]. Gómez-Abellán, P., Madrid, JA., Ordovás, JM., et al.[2023]

Circadian rhythms significantly influence human physiology, with 10-30% of the human genome regulated by circadian molecular clocks, affecting behaviors and biochemical processes.

Chronodisruption (CD), caused by factors like shift work and light exposure at night, is linked to obesity, suggesting that the timing of physiological processes is as important as the factors themselves in understanding obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronobiology and obesity. Garaulet, M., Gómez-Abellán, P.[2013]

In a study of 41 patients with severe obesity who underwent sleeve gastrectomy, significant improvements in circadian rhythm expression were observed 9 months post-surgery, indicating more stable and less fragmented rhythms.

The recovery of circadian rhythms after weight loss was linked to better sleep quality and restored relationships between sleep patterns and circadian rhythms, which were disrupted due to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy in patients with severe obesity restores circadian rhythms and their relationship with sleep pattern. Barnadas Solé, C., Zerón Rugerio, MF., Foncillas Corvinos, J., et al.[2021]

Circadian rhythms play a crucial role in regulating endocrine functions related to fat tissue, affecting metabolism at various levels including systemic and cellular.

Disruptions in these circadian mechanisms are linked to a higher risk of developing type 2 diabetes and obesity, suggesting that targeting circadian pathways could be a new approach for treating metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective influences of circadian clocks in adipose tissue and metabolism. Gimble, JM., Sutton, GM., Bunnell, BA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11745893/

The research progress and prospects of circadian rhythm in ... Numerous studies have shown a link between circadian rhythms disruptions and a higher risk of obesity. This article aims to conduct an extensive ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001388

Role of Circadian Health in Cardiometabolic Health and ... Circadian rhythms regulate metabolism, energy expenditure, and appetite, which are key for healthy weight maintenance, and circadian disruption ...

3. pnas.org pnas.org/doi/10.1073/pnas.2508293122

Circadian-informed modeling predicts regional variation in ... Circadian-informed modeling predicts regional variation in obesity and stroke outcomes under different permanent US time policies · Significance.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11821678/

Circadian Disruption and the Risk of Developing Obesity - PMC Circadian disruptions due to shift work, late time eating and nighttime light exposure are associated with obesity and its metabolic and cardiovascular ...

5. chronobiologyinmedicine.org chronobiologyinmedicine.org/journal/view.php?number=205

Circadian Dysregulation in Obesity Identifying chronotherapeutic targets may help optimize the timing of interventions, improving treatment efficacy and patient outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04665336

The Effect of Circadian Timing Program on Obesity ... Obese individuals with evening chronotype will be trained on sleep hygiene in order to create behavioral changes in line with circadian rhythms and an ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5070789/

Disturbances of sleep and circadian rhythms: Novel risk ... Disturbances of sleep and circadian rhythms have an adverse impact on food choices, hunger and appetite and have lifelong deleterious metabolic effects.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384635/

Circadian Rhythm Disruptions and Cardiovascular Disease Risk Shift work has been increasingly associated with adverse cardiovascular and metabolic health outcomes, as well as adverse psychological effects.