Impact of Eating Duration on Cardiovascular Risk in Short Sleepers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between eating duration and cardiovascular and metabolic health in individuals who habitually sleep less than 6.5 hours per night. Participants will be randomized into two groups: one will continue their usual eating pattern of more than 14 hours a day, while the other will adopt a time-restricted eating schedule limited to 8 hours per day. The study aims to understand how these eating patterns affect metabolic functions and circadian rhythms, particularly in relation to blood pressure and insulin resistance. By exploring these factors, the research seeks to identify alternative strategies for improving health outcomes in habitual short sleepers.

Why it matters

Who can join: the full rules

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 it's running

• Recruiting core Pennington
  Baton Rouge, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Prachi Singh, PhD — Pennington Biomedical Research Institute
• Study coordinator: Prachi Singh, PhD
• Email: prachi.singh@pbrc.edu
• Phone: 225-762-3151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.