RECRUITING

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

Talk to us

Conditions

Sleep Deprivationeating durationshort sleep durationtime-restricted eatingblood pressureinsulin resistance

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-05
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06070194

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18-45 years
  2. * BMI: 25-35 kg/m2
  3. * Habitual sleep duration: ≤6.5 h/night
  4. * Habitual eating period: \>14h/day
  5. * 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.
  6. * Individuals with seasonal allergies will also be included.
  7. * Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
  8. * Must be able to provide written informed consent.
  9. * Ability to follow the prescribed eating duration and maintain habitual diet, sleep and physical activity.
  10. * Use of certain mediations will be allowed including birth control, second generation antihistamines, antacids, acne-related ointments etc.
  1. * Irregular sleep habits / night shift / rotating shift work in past 1 month.
  2. * Frequent travel related jet lag.
  3. * Pregnant/ breast-feeding/ history of irregular menstrual cycles.
  4. * 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).
  5. * Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score \>10).
  6. * Recent changes in body weight (≥5%) within 3 months.
  7. * Uncontrolled depression and /or anxiety, history of psychosis or bipolar disorder.
  8. * 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).
  9. * 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.
  10. * Blood or plasma donation during the past 2 months.

Contacts and Locations

Study Contact

Prachi Singh, PhD
CONTACT
225-762-3151
prachi.singh@pbrc.edu

Principal Investigator

Prachi Singh, PhD
PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Institute

Study Locations (Sites)

Recruiting core Pennington
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • Prachi Singh, PhD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • eating duration
  • short sleep duration
  • time-restricted eating
  • blood pressure
  • insulin resistance

Additional Relevant MeSH Terms

  • Sleep Deprivation