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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted feeding, or eating only during certain hours, can reduce the risk of obesity and diabetes in night shift workers. It focuses on how eating habits during night work affect metabolism, or how the body uses energy. The study will compare two groups: one will eat during nighttime work hours, and the other will fast during those hours. Suitable participants have a normal weight, no significant medical issues, and have lived in high-altitude areas like Denver for at least three months. As an unphased trial, this study offers a unique opportunity to contribute to understanding how meal timing impacts health for night shift workers.

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 prior data suggests that time-restricted feeding is safe for mitigating circadian rhythm disorders?

Research has shown that time-restricted feeding (TRF) can safely and effectively manage weight and improve health. TRF involves eating only during a specific time each day. Studies have found that this method aids weight loss and reduces the risk of diseases like obesity and diabetes.

In past research, most participants found TRF easy to follow and reported few side effects, suggesting its safety for many people.

Overall, TRF has shown promising results in improving health without major safety concerns. It could be a good option for those looking to manage their weight and reduce disease risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted feeding for circadian rhythm disorder because it offers a novel approach by aligning eating patterns with the body's natural biological clock. Unlike traditional treatments that may involve medications or lifestyle modifications to manage sleep-wake cycles, this method explores the timing of food intake as a tool to reset circadian rhythms, particularly for those working overnight shifts. The idea is that fasting during the biological nighttime, when the body expects to rest, might reduce the negative effects of eating at unusual hours. This non-pharmacological strategy could provide a simpler and potentially more natural way to address circadian misalignment.

What evidence suggests that time-restricted feeding could be effective for circadian rhythm disorder?

Research has shown that eating only during certain hours each day, known as time-restricted feeding, can improve health. Studies have found that eating only during the daytime can aid weight loss and lower the risk of heart and metabolic issues. Aligning eating habits with the body's natural clock can enhance sugar processing. In this trial, one group of participants will follow time-restricted feeding during the biological nighttime while staying awake to mimic overnight work shifts. This method might help night shift workers avoid some health problems linked to nighttime eating. Early findings suggest that this eating pattern can effectively reduce health risks for people with irregular schedules. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

You have worked night shifts or traveled across multiple time zones in the three weeks before the study. (You can still participate in the study at a later time.)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5388543/

Fasting, circadian rhythms, and time restricted feeding in ... Time-restricted feeding is a daily eating pattern in which all nutrient intake occurs within a few hours (usually ≤12h) everyday, with no overt attempt to alter ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8143522/

Importance of Aligning Food Habits with the Circadian Clock Early time-restricted eating, based on a limited feeding window per day, reduces cardiometabolic risks by inducing weight loss, and by decreasing markers of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224002219

Time-restricted eating improves health because of energy ... The data indicated that TRE was effective in weight loss and metabolic health, and these benefits were due to a joint effect of energy ...

4. mdpi.com mdpi.com/2072-6643/17/10/1689

The Effectiveness of Time-Restricted Eating as an ... Time-restricted eating (TRE) could improve glucose metabolism by aligning food intake with the circadian clock, but its effectiveness remains unclear.

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1419811/full

The effects of time-restricted eating on sleep in adults Animal studies have shown that time-restricted feeding (TRF) has a positive effect on sleep and health, by aligning food intake with the animal ...

6. academic.oup.com academic.oup.com/edrv/article/43/2/405/6371193

Time-restricted Eating for the Prevention and Management of ... Pilot human intervention studies have reported promising results in reducing the risk for obesity, diabetes, and cardiovascular diseases. Epidemiological ...

7. mdpi.com mdpi.com/2072-6643/12/12/3770

A Systematic Review of Time-Restricted Eating's Effects on ... Time-restricted feeding (TRF) is a form of IF that limits the daily food consumption to a period of 4–12 h, which induces a fasting window of 12 ...