Cardiometabolic Syndrome, Obesity
Conditions
Keywords
Sleep, Circadian Rhythms, Cardiometabolic Health
Brief summary
The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).
Detailed description
A large portion of the U.S. adult population reports insufficient sleep on a nightly basis. It has been shown that sustained insufficient sleep leads to adverse cardiometabolic risk profile and positive energy balance. However, sleep patterns in real life are not consistent over weeks. Individuals not obtaining sufficient sleep during the week may compensate by sleeping longer on weekends. The differences in sleep duration between week and weekend nights is approximately 1 hour, mostly due to delaying wake times rather than advancing bedtimes. A drawback of such behaviors is resultant change in sleep midpoint, which has been associated with adverse cardiometabolic health and obesity. However, very few studies have attempted to determine whether recovery sleep on weekends results in reversal of adverse health effects of insufficient sleep during the week. Available studies suggest that recovery sleep does not revert health markers to pre-sleep restriction (SR) levels. But these studies are short, usually involving only one cycle of SR followed by recovery sleep, and fail to use appropriate and robust statistical methods. Therefore, the goal of the current investigation is to evaluate the impact of repeated intermittent short sleep, with short sleep maintained 5 days/week followed by 2 days of recovery sleep, relative to daily adequate sleep, on energy balance and cardiometabolic risk markers. A secondary goal of this research is to determine if maintaining a constant sleep timing while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep in conjunction with shifts in sleep times.
Interventions
BEHAVIORALIntermittent Short Sleep (ISS)
Restricted sleep duration of \<5.5 h/night for 5 nights (SR) followed by 2 nights of 9.5 hours of time in bed (TIB) (recover sleep) each week.
BEHAVIORALSocial Jetlag (SJL)
2-hour delayed sleep timing.
BEHAVIORALSustained Adequate Sleep (SAS)
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Sponsors
Columbia University
Icahn School of Medicine at Mount Sinai
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician will be blinded to intervention allocation; blinding of study participants is not possible due to the intervention type.
Intervention model description
3-arm, parallel study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 49 years * BMI 20-29.9 kg/m2 * Habitually sleeping 7-9 hours/night without sleep aids or naps
Exclusion criteria
* Sleep disorders * Psychiatric disorders (including eating disorders) and seasonal affective disorder * Pregnancy (current/prior year) * Breastfeeding * Smokers (Any cigarette smoking or ex-smokers \<3years) * Diabetes * Elevated blood pressure, taking beta-blockers * Individuals taking anti-coagulants or anti-platelets * Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure. * Travel across time zones; shift work (non-traditional hours)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma Glucose | Up to 4 weeks | Insulin resistance will be assessed by measuring fasting plasma glucose levels. |
| Insulin Level | Up to 4 weeks | Insulin resistance will be assessed by measuring insulin levels. |
| Morning Systolic and Diastolic Blood Pressure | Up to 4 weeks | Ambulatory blood pressure will be measured. |
| Evening Systolic and Diastolic Blood Pressure | Up to 4 weeks | Ambulatory blood pressure will be measured. |
| Fat mass | Up to 4 weeks | Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low-density Lipoprotein (LDL) Level | Up to 4 weeks | Lipid panel will be assessed. |
| High-density Lipoprotein (HDL) Level | Up to 4 weeks | Lipid panel will be assessed. |
| Total Cholesterol Level | Up to 4 weeks | Lipid panel will be assessed. |
| Triglyceride Level | Up to 4 weeks | Lipid panel will be assessed. |
| C-reactive protein (CRP) Level | Up to 4 weeks | CRP will be measured as an inflammatory marker. |
| Interleukin 6 (IL-6) | Up to 4 weeks | IL-6 will be measured as an inflammatory marker. |
| Tumor necrosis factor alpha (TNF-alpha) | Up to 4 weeks | TNF-alpha will be measured as an inflammatory marker. |
| Total daily energy expenditure | Baseline and endpoint (4 weeks) | Energy expenditure will be measured using doubly-labeled water over 14 days |
| Energy Intake | Baseline and endpoint (4 weeks) | Energy intake will be measured to assess diet quality using daily food records for 7 days. |
| Total Ghrelin | 2 hours post meal at baseline and endpoint (4 weeks) | Total ghrelin will be assessed using radioimmunoassay (RIA). |
| Serum Leptin | 2 hours post meal at baseline and endpoint (4 weeks) | Serum leptin will be measured using a double-antibody RIA. |
| Adiponectin Level | Up to 4 weeks | Adiponectin levels will be analyzed using RIA. |
| Glucagon-like peptide 1 (GLP-1) Level | 2 hours post meal at baseline and endpoint (4 weeks) | GLP-1 will be measured by RIA after plasma extraction with 95% ethanol. |
| Change in Nuclear factor kappa B (NFkB) Level | Baseline and endpoint (4 weeks) | NFkB will be measured to assess endothelial cell inflammation. |
Countries
United States
Contacts
CONTACTMarie-Pierre St-Onge, PhD
CONTACTGreiby Mercedes
PRINCIPAL_INVESTIGATORMarie-Pierre St-Onge, PhD
Columbia University
Outcome results
None listed