Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

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

About this trial

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. 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): 27.5-34.9 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., heart disease, kidney disease)

Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%

Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleep Extension Intervention

    Behavioral

    Sleep extension-based intervention focused on increasing time spent in bed by 2 hours per night by directly scheduling assigned bed and waketimes based on participant's individual schedules. Participants will receive weekly sleep tips and counseling on improving their sleep duration.

Treatment groups

70 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

Total Plasma Ceramides

Total plasma ceramides will be measured by assessing plasma ceramides by targeted metabolomics.

Time frame
Immediately after the intervention
2

Insulin Sensitivity

Insulin sensitivity will be measured by the glucose infusion rate per kg body weight during the hyperinsulinemic-euglycemic clamp.

Time frame
Immediately after the intervention

Secondary outcomes

1

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

Wrist-actigraphy

Time frame
Analyzed as change from baseline for each week of the ~8 week experimental segment
2

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
3

Average (per week) timing of food intake change from baseline

Time of day 50% of calories are consumed collected by picture based food diaries. Average per week will consist of two weekdays and one weekend day

Time frame
During the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.
4

Average (per week) daytime alertness change from baseline

5 point likert scale on daily sleep log (1= most alert; 5 = not alert at all)

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

Other outcomes

Sponsors and contacts

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