Phase
Condition
Insomnia
Sleep Disorders
Treatment
Time restricted eating (TRE)
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 systolicclinical 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 lipidlowering 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 useacceptable 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, sleepand physical activity.
Use of certain mediations will be allowed including birth control, second generationantihistamines, antacids, acne-related ointments etc.
Exclusion
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), andsleep apnea (overnight oximetry defined oxygen desaturation index of >10 events/h ofsleep).
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 apositive response for suicidal thoughts (Q9 of the PHQ-9 - any response other thannot at all).
Any medication or condition that, in the opinion of the medical investigator, couldinterfere with the study outcomes or put the subject at risk by participating in thestudy.
Blood or plasma donation during the past 2 months.
Study Design
Study Description
Connect with a study center
Recruiting core Pennington
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting
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