Time-Restricted Feeding for Circadian Rhythm Disorder

(C2CM Trial)

Overseen By Ellen Lyon, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Must not be taking: Prescribed medications, Supplements, Illicit drugs

Disqualifiers: Medical, Psychiatric, Sleep disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable. This project will examine whether avoiding food intake during the biological night can mitigate the impact of circadian misalignment on metabolic homeostasis in adults during simulated night shift work. Findings from this study could identify a translatable strategy to minimize metabolic diseases in populations that include anyone working nonstandard hours such as police, paramedics, firefighters, military personnel, pilots, doctors and nurses, truck drivers, and individuals with sleep disorders.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed medications, supplements, or illicit drugs at least one month before the study.

What data supports the effectiveness of the treatment Time-Restricted Feeding for Circadian Rhythm Disorder?

Research suggests that time-restricted eating (TRE) can improve metabolic health by reducing body weight, improving glucose tolerance (how well the body processes sugar), and enhancing overall cardiometabolic health. These benefits have been observed in both animal studies and some human studies, indicating potential for managing circadian rhythm disorders. ^{1 2 3 4 5}

Is time-restricted feeding safe for humans?

Time-restricted feeding, where eating is limited to a specific window each day, has been studied in adults with obesity and found to be safe over periods of 8 to 12 weeks, with no significant adverse events reported. ^{1 5 6 7 8}

How is time-restricted feeding different from other treatments for circadian rhythm disorder?

Time-restricted feeding (TRF) is unique because it focuses on limiting the hours during which you eat each day, aligning meal times with your body's natural circadian rhythms. Unlike other treatments that might involve medication or lifestyle changes, TRF specifically targets the timing of food intake to potentially improve metabolic health and restore natural body rhythms. ^{1 4 5 9 10}

Eligibility Criteria

This trial is for adults aged 18-35 with a normal weight (BMI of 20.0-24.9), who are moderately active and get about 7-9 hours of sleep nightly, living at high altitudes like Denver for over three months. It's not for those with significant health issues, drug use in the last month, recent shift work or extensive travel, women with certain gynecological conditions or pregnancy, and non-English speakers.

Inclusion Criteria

You have a "normal" weight, with a body mass index (BMI) between 20.0 and 24.9.

You do not exercise regularly or engage in moderate physical activity.

You usually sleep between 7 and 9.25 hours each night.

Exclusion Criteria

I am a woman less than 1 year after giving birth, currently pregnant or breastfeeding.

Use of prescribed medications/supplements/illicit drugs within one month prior to study.

I do not have any major health, mental, or sleep issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a randomized crossover study with time-restricted feeding during circadian misalignment

4 weeks

Multiple visits for assessments on Days 1-5 and Days 29-33

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Circadian Misalignment
• Time-restricted feeding

Trial Overview The study tests if avoiding food during biological night can help maintain metabolism when one's body clock is off due to simulated night shifts. This could help people working irregular hours avoid obesity and diabetes.

Participant Groups

Group I: Circadian misalignment with time-restricted feeding (Condition B) Experimental Treatment 2 Interventions

Participants will fast during the biological nighttime while remaining awake to mimic overnight work shifts.

Group II: Circadian misalignment (Condition A) Experimental Treatment 1 Intervention

Participants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

Findings from Research

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 study of 38,302 adults, a longer eating window was linked to a lower prevalence of obesity, suggesting that allowing more time for eating may not be as harmful as previously thought.

Conversely, longer fasting periods in the morning and evening were associated with a higher prevalence of obesity, indicating that the timing of eating relative to sleep may play a significant role in weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian timing of eating and BMI among adults in the American Time Use Survey. O'Connor, SG., Reedy, J., Graubard, BI., et al.[2023]

Time-restricted eating (TRE) in humans, which involves consuming all calories within a consistent window of less than 12 hours, shows promise in reducing the risk of obesity, diabetes, and cardiovascular diseases, supported by both animal studies and pilot human interventions.

The approach is based on the understanding of circadian rhythms and their influence on metabolism, suggesting that maintaining a regular feeding schedule can help sustain these rhythms and potentially improve health outcomes, although further clinical studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted Eating for the Prevention and Management of Metabolic Diseases. Manoogian, ENC., Chow, LS., Taub, PR., et al.[2022]

Time-restricted eating (TRE), which limits calorie intake to 6- to 10-hour periods during the active part of the day, has been shown to improve various aspects of metabolic health, including weight loss, glucose tolerance, and cardiovascular health, based on both preclinical and human studies.

Implementing TRE can help mitigate the negative effects of eating out of sync with our body's natural circadian rhythms, potentially reducing the risk of chronic diseases, although there are challenges in applying this dietary approach in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. Regmi, P., Heilbronn, LK.[2021]

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 an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

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]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

In a study involving 15 men over 8 weeks, time-restricted eating (TRE) significantly altered 24-hour profiles of key metabolic markers, including insulin and triglycerides, suggesting potential benefits for metabolic health.

TRE also influenced the expression of genes related to circadian rhythms and transcriptional regulation in subcutaneous adipose tissue, indicating a mechanism by which TRE may improve metabolic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating alters the 24-hour profile of adipose tissue transcriptome in men with obesity. Zhao, L., Hutchison, AT., Liu, B., et al.[2023]

In an 8-week study of time-restricted feeding (TRF) involving 32 women (13 premenopausal and 19 postmenopausal), both groups experienced similar weight loss of about 3.3% without any significant differences between them.

Both premenopausal and postmenopausal women showed reductions in fat mass, lean mass, fasting insulin, and oxidative stress markers, indicating that TRF can provide metabolic benefits regardless of menopausal status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. Cienfuegos, S., Gabel, K., Kalam, F., et al.[2023]

References

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

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

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

Circadian timing of eating and BMI among adults in the American Time Use Survey. [2023]

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

Time-restricted Eating for the Prevention and Management of Metabolic Diseases. [2022]

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

Time-Restricted Eating: Benefits, Mechanisms, and Challenges in Translation. [2021]

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

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

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

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

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

Time-restricted eating alters the 24-hour profile of adipose tissue transcriptome in men with obesity. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Changes in body weight and metabolic risk during time restricted feeding in premenopausal versus postmenopausal women. [2023]