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

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Sep 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how short sleep and long eating hours can affect heart health and metabolism. Researchers want to see if limiting the time participants eat to just 8 hours each day can help improve health for those who usually sleep less than 6.5 hours a night and eat for more than 14 hours a day. By understanding these habits, the study hopes to find ways to reduce risks like high blood pressure and poor blood sugar control in people who don’t get enough sleep.

To be eligible for this study, participants need to be between 18 and 45 years old, have a body mass index (BMI) between 25 and 35, and sleep less than 6.5 hours each night. They should also be eating for more than 14 hours each day but not have certain health issues like high blood pressure, diabetes, or heart disease. During the trial, participants will follow a specific eating schedule while maintaining their usual diet and sleep patterns. It’s important for potential participants to know that some medications are allowed, and they need to be able to provide consent to join the study.

Gender

ALL

Eligibility 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.