Circadian Intervention to Improve Cardiometabolic Health
NCT ID: NCT05943626
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-06-13
2026-03-31
Brief Summary
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Detailed Description
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Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an \~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control Group
Provided with general health information on diet and physical activity.
No interventions assigned to this group
Intervention Group
Circadian-based intervention focused on timing of light exposure and food intake.
Circadian Intervention
The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Interventions
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Circadian Intervention
The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and to finish all food consumption at least 4 hours before bedtime.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI): 25.0-34.9 kg/m2,
3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months
Exclusion Criteria
2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
3. Use of prescription drugs or substances known to influence sleep or glucose metabolism
4. Shift-work: current or history of within last year
5. Weight change: \>10% of body weight over prior six months
6. Experiencing menopause or post-menopausal
7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
8. Currently pregnant or planning to become pregnant, or currently lactating.
9. Currently smoking
10. Alcohol intake \>3 drinks per day or \>14 drinks per week
18 Years
45 Years
ALL
Yes
Sponsors
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University of Utah
OTHER
Responsible Party
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Christopher Depner
Assistant Professor
Locations
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College of Health Research Complex--University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Christopher Depner
Role: primary
Other Identifiers
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22-60
Identifier Type: -
Identifier Source: org_study_id