Biorhythms in Metabolic Tissues (NCT03276442) | Clinical Trial Compass
UnknownNot Applicable
Biorhythms in Metabolic Tissues
Sweden12 participantsStarted 2017-08-31
Plain-language summary
Metabolism is increasingly recognized as being highly regulated by anticipatory biological rhythms (circadian rhythms or "biorhythms"), which are driven by molecular feedback loops, and which are approximately 24 hours long ("circa diem"). These circadian rhythms exist both centrally, in the brain, but also in the periphery, and are specific to many tissues depending on their main biological function or functions. Whereas these circadian rhythms have been thoroughly characterized in other organisms, their role in humans remain poorly understood, partly because of the difficulty in studying these rhythms in peripheral tissues. The investigators therefore aim to characterize these rhythms in primarily skeletal muscle and adipose tissue in healthy young volunteers (using the so-called constant routine paradigm), and how these rhythms interact with one another at various genetic and molecular levels. At the same time, the investigators aim to study how an unhealthy vs. healthy diet can alter these circadian rhythms, and how they interact with circadian rhythms in other tissue compartments such as those expressed by blood cells.
Who can participate
Age range
18 Years – 32 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-33 yr
* Healthy (self-reported) and not on medication
* BMI 18-28 kg/m2 (and waist circumference \<102 cm), and weight stable (±5% body weight in past 6 months)
* Non-smoker and non-nicotine user
* Regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night
* Sedentary to moderately active with regular exercise habits the last 2 months
* Regular daily meal pattern with 3 main meals
Exclusion Criteria:
* Major or chronic illness, e.g. diabetes, renal disease or inflammatory bowel disease
* Current or history of endocrine or metabolic disorders
* Psychiatric or neurological disorders (e.g. bipolar disorder, epilepsy)
* Frequent gastrointestinal symptoms
* Chronic medication
* Any sleep disorder (e.g. irregular bedtimes, symptoms of insomnia)
* Any issues with or allergies against the provided food items or utilized anesthesia
* Shift work in the preceding three months or for a long duration
* Time travel over two time zones in the preceding month
* Too much weight gain or weight loss in the preceding 6 months
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in clock gene & associated omic circadian rhythms
Timeframe: Measured repeatedly (every 6 hours for 24 hours) during a period of extended wakefulness, following each dietary intervention (i.e. over a total period of 6-7 weeks)