Impact of Eating Duration on Cardiovascular Risk in Short Sleepers
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
This study is testing if changing the eating hours of people who sleep less than 6.5 hours a night can improve their heart and metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT06070194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-45 with a BMI between 25-35 who sleep 6.5 hours or less per night and have an eating duration of more than 14 hours per day.
Not a fit: Patients with chronic health conditions such as hypertension, dyslipidemia, diabetes, or cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to reduce cardiovascular and metabolic risks in individuals with short sleep duration.
How similar studies have performed: While the specific approach of time-restricted eating in habitual short sleepers is relatively novel, similar studies have shown promising results in improving metabolic health through dietary interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baton Rouge, Louisiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.