Sleep and Metabolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorOregon Health and Science University
About this trial
The goal of this study is to uncover sleep and circadian mechanisms contributing to adverse metabolic health. The protocol is a 21 day (7 outpatient days, 14 inpatient days) mechanistic randomized-crossover study designed to identify the impact of chronic sleep restriction and circadian timing, independently and in combination on energy metabolism and identify the independent and combined effects on glucose tolerance.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between 18 and 40 years of age
Drug free
Established disease-free status
Disqualifiers
Dietary restrictions
Participants who choose not to or cannot consume dairy products (milk, yogurt, cheese, ice cream)
Body Composition
Psychiatric/psychological suitability
Trial design
Design model
Crossover
Treatments tested in this trial
Sleep Restriction
BehavioralParticipants are randomized into either a group (n=10) that is sleep restricted first or control first (n=10) group; the groups will crossover halfway through the protocol. Both arms are fed 3 meals and have access to ad libitum food between meals. Both groups will also undergo up to 3 mixed-meal tolerance tests to measure glucose tolerance.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Sleep Restriction FirstExperimental treatment 1 intervention
Group B: Controlled Condition FirstNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Circadian Phase
Saliva will be assayed for melatonin used standardized assays. Melatonin will be sampled at 1h intervals during wakefulness. Melatonin onset will be calculated using the linear interpolated time at which melatonin levels reach 25% of a fitted peak-to-trough amplitude.
Time frame
14 days2
Energy Intake
Throughout the forced desynchrony protocol, participants will have ad libitum access to food, which will be scored using NDSR software. NDSR was developed to help plan, manage, and analyze food and nutrient intake. Each meal and set of snacks will be timestamped (midpoint of snack availability) and binned by circadian phase based on the individuals' melatonin and also by time awake.
Time frame
14 days3
Energy Content
Throughout the forced desynchrony protocol, participants will have ad libitum access to food, which will be scored using NDSR software. NDSR was developed to help plan, manage, and analyze food and nutrient intake. Each meal and set of snacks will be timestamped (midpoint of snack availability) and binned by circadian phase based on the individuals' melatonin and also by time awake.
Time frame
14 days4
Glucose Metabolism
The participant's glucose and insulin response to a mixed meal diet high in carbohydrates may be tested up to 3 times during the protocol (Days 2, 4, and 13). Each participant will have a choice of 1 of 2 meal options and will be given that meal throughout the study. During this mixed meal test, a baseline blood draw will occur \~7-min before the meal and then the frequency of blood samples will increase to every 10-min after the meal for 90 min and then every 30 min for 90 min for a total of 14 samples (\~1 mL each, total of \~14 mL) over 180 minutes to measure glucose and hormone response in detail. Samples at each time point will be obtained for measurement of suppressibility of plasma free fatty acids. Blood will also be drawn every 4h during the protocol for 24h insulin and glucose.
Time frame
~3 daysSponsors and contacts
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Source ClinicalTrials.gov