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Time-Restricted Feeding for Circadian Rhythm Disorder (C2CM Trial)
N/A
Recruiting
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change to be assessed at day 3, day 5, day 31, day 33.
Awards & highlights
C2CM Trial Summary
This trial will study whether not eating during the night can help mitigate the impact of circadian misalignment on metabolism in people who work nonstandard hours.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include hunger at unusual times or discomfort adjusting to new eating schedules but no specific medical side effects are anticipated.
C2CM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change to be assessed at day 3, day 5, day 31, day 33.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change to be assessed at day 3, day 5, day 31, day 33.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin sensitivity-derived from glucose tolerance test
Muscle tissue lipids-assessed by lipidomic analyses
Secondary outcome measures
24-hour circulating blood free fatty acid levels-assessed by assay
24-hour circulating blood glucose levels-assessed by assay
24-hour circulating blood insulin levels-assessed by assay
Other outcome measures
Cognitive assessments- Conjunction Visual Search Task
Cognitive assessments- Psychomotor Vigilance Task
Cognitive assessments-Karolinska Sleepiness Scale
+8 moreC2CM Trial Design
2Treatment groups
Experimental Treatment
Group I: Circadian misalignment with time-restricted feeding (Condition B)Experimental Treatment2 Interventions
Participants will fast during the biological nighttime while remaining awake to mimic overnight work shifts.
Group II: Circadian misalignment (Condition A)Experimental Treatment1 Intervention
Participants will eat meals during the biological nighttime while remaining awake to mimic overnight work shifts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-restricted feeding
2018
N/A
~50
Circadian Misalignment
2016
N/A
~20
Find a Location
Who is running the clinical trial?
University of Colorado, DenverOTHER
1,735 Previous Clinical Trials
2,149,139 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,463 Total Patients Enrolled
Salk Institute for Biological StudiesOTHER
19 Previous Clinical Trials
1,775 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 35 years old.I am a woman less than 1 year after giving birth, currently pregnant or breastfeeding.I speak English and can understand the consent and study information without a translator.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.I do not have any major health, mental, or sleep issues.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.)You usually sleep between 7 and 9.25 hours each night.You have lived at a high altitude like Denver for at least 3 months before staying in the hospital for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Circadian misalignment with time-restricted feeding (Condition B)
- Group 2: Circadian misalignment (Condition A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I a viable candidate to join this medical research project?
"Patients who meet the criteria of being 18-35 years old and having a metabolic disorder are eligible to participate in this trial. Currently, 32 individuals have been enrolled."
Answered by AI
Is it permissible for individuals under the age of 20 to enroll in this research?
"Patients aged between 18 and 35 are eligible to enrol in this clinical investigation. Separately, 77 trials were identified for minors under the age of 18 while 226 studies aimed at elderly persons over 65 exist."
Answered by AI
Is this investigative endeavor accepting new participants?
"Yes, the clinical trial is still recruiting participants. As per information on clinicaltrials.gov, this study was first posted on July 7th 2021 and recently updated August 1st 2022; 32 individuals are required to take part at a single location."
Answered by AI
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