RecruitingNot ApplicableNCT06070194

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

Sponsor

Pennington Biomedical Research Center

Enrollment

100 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Sleep Deprivation

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria10

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 Criteria10

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.

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Interventions

BEHAVIORALTime 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.