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

NCT06070194 | Recruiting

• 2 other identifiers: PBRC 2023-025R01HL166306
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in 24h mean arterial blood pressure (MAP)

  Change in 24h MAP from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.

  Baseline to 4 weeks

• Change in insulin resistance

  Change in insulin resistance from pre-intervention to end-intervention. Insulin resistance will be determined by standard 3h mixed meal tolerance test and calculated as ratio of incremental area under the curve values for insulin and glucose. Difference between habitual eating period and TRE will be evaluated.

  Baseline to 4 weeks

Secondary Outcomes (2)

• Change in 24h systolic blood pressure (SBP)

  Baseline to 4 weeks

• Change in postprandial glycemic excursion

  Baseline to 4 weeks

Other Outcomes (3)

• Change in clock time for dim light melatonin onset

  Baseline to 4 weeks

• Change in clock time for dim light melatonin offset

  Baseline to 4 weeks

• Change in melatonin area under the curve (AUC)

  Baseline to 4 weeks

Study Arms (2)

Time restricted eating (TRE)

EXPERIMENTAL

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

Behavioral: Time restricted eating (TRE)

Habitual eating duration

NO INTERVENTION

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

Interventions

Time restricted eating (TRE) BEHAVIORAL

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.

Time restricted eating (TRE)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Recruiting core Pennington

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation; Intermittent Fasting; Insulin Resistance

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Fasting; Feeding Behavior; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Prachi Singh, PhD

  Pennington Biomedical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prachi Singh, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 6, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)