Recruiting

Observational Study

Sponsor:

Pennington Biomedical Research Center

Code:

NCT06070194

Conditions

Sleep Deprivation

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Time restricted eating (TRE)

Study Details

Brief summary:

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.

Conditions

Sleep Deprivation

Study ID

NCT06070194

Start date

Dec 5, 2023

Status verified date

Feb, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Time restricted eating (TRE)

Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks.

no intervention: Habitual eating duration

Subjects randomized to this arm will be asked to continue habitual eating duration of >14h/day for 4 weeks.

Interventions

Time restricted eating (TRE)

Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks. Participants will be asked to continue habitual sleep patterns.

Primary outcome measure

  • Change in 24h mean arterial blood pressure (MAP) [ Time Frame: Baseline to 4 weeks ]
  • Change in insulin resistance [ Time Frame: Baseline to 4 weeks ]

Central Contacts and Locations

Central contacts

Prachi Singh, PhD

225-762-3151prachi.singh@pbrc.edu

Locations

Recruiting core Pennington

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Recruiting core Pennington

2257633000ClinicalTrials@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-02-10.