NCT06070194 · Pennington Biomedical Research Center
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
(CRISP)
What this study is about
Short sleep duration confers high cardiovascular and metabolic risk, but lifestyle factors and molecular mechanisms that contribute to increased blood pressure and poor glucose control during short sleep are not completely understood. Habitual short sleepers are constantly eating, the proposed studies will evaluate if this behavior contributes to heightened cardiovascular and metabolic risk.
View original scientific description
Short sleep duration confers high cardiovascular and metabolic risk, but lifestyle factors and molecular mechanisms that contribute to increased blood pressure and poor glucose control during short sleep are not completely understood. Habitual short sleepers are constantly eating, the proposed studies will evaluate if this behavior contributes to heightened cardiovascular and metabolic risk. The study will evaluate if restricted eating duration (8 hours/day) could improve cardiovascular and metabolic health in habitual short sleepers.
Interventions
BEHAVIORAL
Time restricted eating (TRE)
Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks. Participants will be asked to continue habitual sleep patterns.
Primary outcome measures
Change in 24h mean arterial blood pressure (MAP)
Time frame: Baseline to 4 weeks
Change in 24h MAP from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.
Change in insulin resistance
Time frame: Baseline to 4 weeks
Change in insulin resistance from pre-intervention to end-intervention. Insulin resistance will be determined by standard 3h mixed meal tolerance test and calculated as ratio of incremental area under the curve values for insulin and glucose. Difference between habitual eating period and TRE will be evaluated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: 18-45 years
- BMI: 25-35 kg/m2
- Habitual sleep duration: ≤6.5 h/night
- Habitual eating period: \>14h/day
- Absence of chronic health conditions including hypertension (defined as systolic clinical BP of \>140 or diastolic BP of \>90 mmHg or use of BP lowering drugs), dyslipidemia (defined as LDL \>190mg/dL or Triglycerides \>400 mg/dL or use of lipid lowering medications), diabetes (defined as fasting glucose \>126 mg/dL and /or HbA1C \>6.5%, or use of glucose lowering medication), and cardiovascular disease. However, individuals with prehypertension, and/or prediabetes will be allowed to participate.
- Individuals with seasonal allergies will also be included.
- Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
- Must be able to provide written informed consent.
- Ability to follow the prescribed eating duration and maintain habitual diet, sleep and physical activity.
- Use of certain mediations will be allowed including birth control, second generation antihistamines, antacids, acne-related ointments etc.
Exclusion criteria
- Irregular sleep habits / night shift / rotating shift work in past 1 month.
- Frequent travel related jet lag.
- Pregnant/ breast-feeding/ history of irregular menstrual cycles.
- Sleep disorders such as insomnia (defined as Insomnia Severity Index score ≥15), and sleep apnea (overnight oximetry defined oxygen desaturation index of \>10 events/h of sleep).
- Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score \>10).
- Recent changes in body weight (≥5%) within 3 months.
- Uncontrolled depression and /or anxiety, history of psychosis or bipolar disorder.
- Uncontrolled depression and/or depression is defined as PHQ-9 score of ≥15 or a positive response for suicidal thoughts (Q9 of the PHQ-9 - any response other than not at all).
- Any medication or condition that, in the opinion of the medical investigator, could interfere with the study outcomes or put the subject at risk by participating in the study.
- Blood or plasma donation during the past 2 months.
Where
- Baton Rouge, Louisiana
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations