Food and Circadian Timing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorOregon Health and Science University
About this trial
The goals of this study are to uncover the influence of diet on the human circadian timing system. The protocol is a 46-day (28 outpatient days, 18 inpatient days over two 9 day visits) randomized cross-over study designed to elucidate the speed of entrainment in response to a high-fat diet.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy, lean men and women
Disqualifiers
Major dietary restrictions (such as entirely dairy-free and/or meat-free diets)
A body mass index (BMI) of 18.5< [BMI] < 24.9 kg/m² and a waist circumference <94/80cm
Currently psychiatrically/psychologically unsuitable for participation
Drug/alcohol use, including smoking
Trial design
Design model
Crossover
Treatments tested in this trial
High-Fat Diet
Other interventionThe diet will consist of a breakfast, lunch, dinner, and snack
Low-Fat Diet
Other interventionThe diet will consist of a breakfast, lunch, dinner, and snack
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: High-Fat DietExperimental treatment 1 intervention
Group B: Low-Fat DietActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Speed of entrainment
Entrainment will be determined as a stable phase angle between sleep and both melatonin onset. Blood and/or saliva will be assayed for melatonin using standardized assays. Melatonin onset will be calculated using the linear interpolated time at which melatonin levels reach 25% of a fitted peak-to-trough amplitude. This will be analyzed using phase angle between sleep and melatonin onset.
Time frame
Over 18 daysSecondary outcomes
1
Change in Phase Angle of entrainment
Phase angle will be calculated as dim-light melatonin onset minus sleep onset during each constant posture protocol. Differences in phase angle of entrainment between sleep and melatonin onset will be first examined using planned comparison dependent t-tests between the high-fat and low-fat visits. The study will use planned comparison dependent t-tests to compare phase angle of entrainment from constant posture day 1 vs constant posture day 2 to uncover potential differences in phase angle in response to an advance in light exposure under differing diet conditions
Time frame
Over 18 days2
Change in Core Body Temperature Entrainment
Core body temperature entrainment will be determined as a stable phase angle between sleep and core body temperature minimum. Temperature data will be collected every minute though rectal thermistors.
Time frame
Over 18 days3
Change in Core Body Temperature Phase angle of Entrainment
Core body temperature entrainment will be determined as core body temperature minimum minus sleep onset. Temperature data will be collected every minute though rectal thermistors.
Time frame
Over 18 days4
Change in glucose tolerance
The participant's glucose and insulin response to a mixed meal diet high in carbohydrates may be tested. 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 12 samples over 180 min to measure glucose and hormone response in detail. Examined using planned comparison dependent t-tests between the high-fat and low-fat visits.
Time frame
Over 18 daysSponsors and contacts
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Oregon Health and Science University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov