Circadian Intervention for Obesity

(TOCS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Must not be taking: Sleep aids, Glucose regulators

Disqualifiers: Sleep disorder, Diabetes, Cardiovascular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

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 data supports the effectiveness of the Circadian Intervention treatment for obesity?

Research shows that disruptions in circadian rhythms (the body's internal clock) are linked to obesity, and improving these rhythms can help regulate metabolism and energy balance. Studies suggest that aligning daily activities with natural circadian patterns may reduce obesity risk and improve sleep quality, making circadian interventions a promising approach for weight management. ^{1 2 3 4 5}

How does the Circadian Intervention treatment for obesity differ from other treatments?

Circadian Intervention is unique because it focuses on aligning the body's internal clock (circadian rhythm) to improve metabolism and energy balance, which are often disrupted in obesity. Unlike traditional treatments that may focus on diet or exercise alone, this approach targets the timing of these activities to synchronize with the body's natural rhythms, potentially enhancing their effectiveness. ^{1 3 6 7 8}

Research Team

Eligibility Criteria

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

I am between 18 and 45 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• Circadian Intervention (Behavioral 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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

College of Health Research Complex--University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Findings from Research

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]

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, 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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

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

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

Sleeve gastrectomy in patients with severe obesity restores circadian rhythms and their relationship with sleep pattern. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Prospective influences of circadian clocks in adipose tissue and metabolism. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Chronobiological aspects of food intake and metabolism and their relevance on energy balance and weight regulation. [2011]

6. Spain pubmed.ncbi.nlm.nih.gov

[Chronobiological aspects of obesity and metabolic syndrome]. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Circadian rhythms and obesity: Timekeeping governs lipid metabolism. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Chronobiology and obesity. [2013]