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RECRUITING

NCT06070194

Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period

Sponsor: Pennington Biomedical Research Center

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-12-05

Completion Date

2028-06-30

Last Updated

2026-02-10

Healthy Volunteers

Yes

Conditions

Sleep Deprivation

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.

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.

Locations (1)

Recruiting core Pennington

Baton Rouge, Louisiana, United States