Circadian Intervention to Improve Cardiometabolic Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Utah

About this trial

The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-45 years old; equal numbers of men and women

Body mass index (BMI): 25.0-34.9 kg/m2,

Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months

Disqualifiers

Clinically diagnosed sleep disorder or major psychiatric illness

Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)

Use of prescription drugs or substances known to influence sleep or glucose metabolism

Shift-work: current or history of within last year

Trial design

Design model

Parallel

Treatments tested in this trial

  • Circadian Intervention

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Insulin sensitivity change from baseline

Oral Glucose Tolerance Test (OGTT), Matsuda Index

Time frame
Change from baseline to end of the ~8 week experimental segment

Secondary outcomes

1

Timing of central circadian clock change from baseline

Quantified as dim-light melatonin onset from salivary melatonin samples

Time frame
Change from baseline to end of the ~8 week experimental segment
2

Plasma ceramides change from baseline

Fasting plasma samples will be analyzed for plasma ceramides using targeted metabolomics

Time frame
Change from baseline to end of the ~8 week experimental segment
3

Average (per week) nightly total sleep time change from baseline

Analyzed by wrist-actigraphy

Time frame
Analyzed as change from baseline for each week of the ~8 week experimental segment
4

Average (per week) sleep satisfaction change from baseline

5 point likert scale on daily sleep log (1 = very good; 5 = very poor)

Time frame
Analyzed as change from baseline for each week of the ~8 week experimental segment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.