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NCT Number: NCT06070194

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

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recruiting core Pennington

Baton Rouge, Louisiana, 70808, United States

Location status: Recruiting

Location contact

Recruiting core Pennington

CONTACT

[email protected]

2257633000

About this study

Short sleep duration is associated with increased cardiovascular and metabolic risk with consequent increased cardiovascular mortality. Increasing sleep duration mitigates the metabolic impairment, but alternate strategies to reduce cardiometabolic risk in habitual short sleepers are lacking. This is especially important when increasing sleep duration is unsuccessful. Unfortunately, the underlying mechanisms through which shortened sleep contributes to metabolic detriments are not completely understood. This hinders the development of alternate strategies for cardiovascular prevention in short sleepers. However, a widespread factor potentially underlying metabolic dysfunction in short sleepers seems to be circadian misalignment (decreased and delayed melatonin secretion) partly resulting from mistimed eating. Importantly, eating behavior may be targeted to improve metabolism in short sleepers. Specifically, limiting the daily eating period as shown by the many recent interventions of time restricted eating (TRE) may potentiate circadian alignment (melatonin rhythms) and improve metabolism in habitual short sleepers.

The goal of the study is to examine the metabolic and circadian effects of eating duration in habitual short sleepers. The investigators propose a two-group, parallel arm study during which participants will be randomized to either continue with habitual >14h/day (extended) or restricted 8h/day (TRE) eating duration. The overarching hypothesis is that extended eating duration contributes to high blood pressure (BP), insulin resistance (IR), and a decreased and delayed melatonin secretion in habitual short sleepers. Therefore, TRE will reduce BP, IR along with an increased and earlier onset of melatonin secretion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in 24h mean arterial blood pressure (MAP)

    Time frame: Baseline to 4 weeks

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

  2. Change in insulin resistance

    Time frame: Baseline to 4 weeks

    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.

Secondary outcomes

  1. Change in 24h systolic blood pressure (SBP)

    Time frame: Baseline to 4 weeks

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

  2. Change in postprandial glycemic excursion

    Time frame: Baseline to 4 weeks

    Change in postprandial glycemic excursion from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.

Other outcomes

  1. Change in clock time for dim light melatonin onset

    Time frame: Baseline to 4 weeks

    Change in clock time for dim light melatonin onset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.

  2. Change in clock time for dim light melatonin offset

    Time frame: Baseline to 4 weeks

    Change in clock time for dim light melatonin offset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.

  3. Change in melatonin area under the curve (AUC)

    Time frame: Baseline to 4 weeks

    Change in AUC from melatonin onset to offset from pre-intervention to end-intervention. Difference between habitual eating period and TRE will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Prachi Singh, PhD

CONTACT

[email protected]

225-762-3151

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: CRISP

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 6, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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