Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
Recruiting
N/AInterventional Study
Sleep Deprivation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
100 (estimated)
Sponsor
Pennington Biomedical Research Center · Other
Who this trial is looking for
This trial is looking for people who usually sleep less than 6.5 hours a night and eat for more than 14 hours a day. Participants will follow a restricted eating schedule of 8 hours a day to see if it can help their heart and health.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 45 years old.
I have a body mass index (BMI) between 25 and 35.
I usually sleep 6.5 hours or less each night.
I typically eat for more than 14 hours a day.
I do not have chronic health conditions affecting my heart or blood sugar.
I have seasonal allergies.
I can give written consent to participate.
You may not be able to join if
I have irregular sleep habits or have worked night shifts in the past month.
I have frequently traveled and experienced jet lag.
I am pregnant, breastfeeding, or have irregular menstrual cycles.
I have sleep disorders, like insomnia or sleep apnea.
I feel excessively sleepy during the day.
I have had a significant weight change in the last 3 months.
I have serious depression, anxiety, or a history of bipolar disorder or psychosis.
I have donated blood or plasma in the last 2 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 s…
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.
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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), dy…
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.
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