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

Last updated: December 11, 2024
Sponsor: Pennington Biomedical Research Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Sleep Disorders

Treatment

Time restricted eating (TRE)

Clinical Study ID

NCT06070194
PBRC 2023-025
R01HL166306
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Time restricted eating (TRE)
Phase:
Study Start date:
December 05, 2023
Estimated Completion Date:
June 30, 2028

Study Description

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.

Connect with a study center

  • Recruiting core Pennington

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

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