Clinical trial NCT05880758: Impact of Yo-Yo Sleep on Cardiometabolic Health
Official title: Impact of Yo-Yo Sleep on Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Syndrome
Obesity
Keywords: Sleep
Circadian Rhythms
Cardiometabolic Health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: University of Colorado, Denver
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm, parallel study design
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fasting Plasma Glucose
timeFrame: Up to 4 weeks
measure: Insulin Level
timeFrame: Up to 4 weeks
measure: Morning Systolic and Diastolic Blood Pressure
timeFrame: Up to 4 weeks
measure: Evening Systolic and Diastolic Blood Pressure
timeFrame: Up to 4 weeks
measure: Fat mass
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Low-density Lipoprotein (LDL) Level
timeFrame: Up to 4 weeks
measure: High-density Lipoprotein (HDL) Level
timeFrame: Up to 4 weeks
measure: Total Cholesterol Level
timeFrame: Up to 4 weeks
measure: Triglyceride Level
timeFrame: Up to 4 weeks
measure: C-reactive protein (CRP) Level
timeFrame: Up to 4 weeks
measure: Interleukin 6 (IL-6)
timeFrame: Up to 4 weeks
measure: Tumor necrosis factor alpha (TNF-alpha)
timeFrame: Up to 4 weeks
measure: Total daily energy expenditure
timeFrame: Baseline and endpoint (4 weeks)
measure: Energy Intake
timeFrame: Baseline and endpoint (4 weeks)
measure: Total Ghrelin
timeFrame: 2 hours post meal at baseline and endpoint (4 weeks)
measure: Serum Leptin
timeFrame: 2 hours post meal at baseline and endpoint (4 weeks)
measure: Adiponectin Level
timeFrame: Up to 4 weeks
measure: Glucagon-like peptide 1 (GLP-1) Level
timeFrame: 2 hours post meal at baseline and endpoint (4 weeks)
measure: Change in Nuclear factor kappa B (NFkB) Level
timeFrame: Baseline and endpoint (4 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Marie-Pierre St-Onge, PhD
role: PRINCIPAL_INVESTIGATOR
References: