Biomarkers of Increased Free Living Sleep Time (NCT04214184) | Clinical Trial Compass
CompletedNot Applicable
Biomarkers of Increased Free Living Sleep Time
United States38 participantsStarted 2019-12-02
Plain-language summary
This protocol will increase sleep duration in participants who maintain less than 6 hours sleep per night, to target the recommended 7 hours of sleep per night. The focus of this study is determine how increasing nightly sleep duration in these individuals who maintain less than 6 hours sleep per night changes their plasma metabolome and insulin sensitivity. The primary outcome will examine changes in branched-chain amino acids and the secondary outcome will examine changes in insulin sensitivity. The investigators will also determine if changes in plasma metabolites can be used as a biomarker to discriminate between adequate versus insufficient sleep.
Who can participate
Age range18 Years ā 35 Years
SexALL
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Inclusion criteria
ā. 18-35 years old; men and women
ā. Body Mass Index (BMI) of \> 18.5 and \<24.9.
ā. Inactive to habitual moderate physical activity level (\<5 days of exercise per week).
ā. Sleep/wake history: habitual sleep duration less than 6 hours per night.
ā. Altitude history: Potential participants must have lived at Denver altitude or higher for at least 3 months.
Exclusion criteria
ā. Any clinically significant unstable medical or surgical condition within the last year (treated or untreated).
ā. Any clinically significant psychiatric condition, as defined by DSM-IV-TR. I
ā. Any clinically significant sleep disorder.
ā. Use of prescription medications/supplements within one month or need of these medications at any time during the study.
ā
What they're measuring
1
Metabolomics-branched chain amino acids change from baseline
Timeframe: Morning fasted blood will be collected for analyses at baseline and after the four week increased sleep duration intervention.
2
Insulin Sensitivity change from baseline
Timeframe: Oral glucose tolerance testing will take about 3 hours to complete, and will be tested at baseline and after the four week increased sleep duration intervention.