Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID06070194

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

Led by Pennington Biomedical Research Center · Updated on 2026-02-10

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Pennington Biomedical Research Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how eating duration affects cardiovascular and metabolic health in adults who habitually sleep less than 6.5 hours per night. Short sleep duration is linked to increased risks of heart and metabolic problems, but the exact lifestyle factors and biological mechanisms causing high blood pressure and poor blood sugar control in these individuals are not fully known. The study focuses on whether limiting the daily eating window can improve these health risks by correcting circadian misalignment caused by extended eating times. Participants will be randomly assigned to one of two groups for four weeks: one group will follow a time restricted eating (TRE) plan limiting food intake to 8 hours per day, while the other group will continue their usual eating pattern lasting more than 14 hours daily. Both groups will maintain their habitual sleep schedules. The study will assess how these different eating durations impact blood pressure, insulin resistance, and melatonin secretion patterns. During the study, participants will be monitored for changes in 24-hour mean arterial blood pressure and insulin resistance from baseline to four weeks. Additional measures include 24-hour systolic blood pressure and post-meal blood sugar levels. Participants' adherence to the eating schedules, sleep patterns, and physical activity will be tracked. The total study duration for each participant is four weeks, during which various health assessments and metabolic tests will be conducted to evaluate the effects of eating duration on cardiovascular and metabolic health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 45 years
  • Body mass index (BMI) between 25 and 35 kg/m2
  • Habitual sleep duration of 6.5 hours or less per night
  • Habitual eating period longer than 14 hours per day
  • No chronic health conditions including hypertension, dyslipidemia, diabetes, or cardiovascular disease, but prehypertension and prediabetes are allowed
  • Inclusion of individuals with seasonal allergies
  • Women of child-bearing age must agree to use acceptable birth control during the study
  • Ability to provide written informed consent
  • Ability to follow prescribed eating duration and maintain habitual diet, sleep, and physical activity
  • Allowed use of certain medications such as birth control, second generation antihistamines, antacids, and acne-related ointments
Not Eligible

You will not qualify if you...

  • Irregular sleep habits, night shift, or rotating shift work in the past month
  • Frequent travel causing jet lag
  • Pregnant, breastfeeding, or history of irregular menstrual cycles
  • Sleep disorders including insomnia with a severity index score of 15 or higher, or sleep apnea with oxygen desaturation index over 10 events per hour
  • Excessive daytime sleepiness with a score over 10 on the Epworth Sleepiness Scale
  • Recent body weight changes of 5% or more within 3 months
  • Uncontrolled depression or anxiety, history of psychosis or bipolar disorder
  • Depression defined by a PHQ-9 score of 15 or higher or positive suicidal thoughts
  • Any medication or condition that might interfere with study outcomes or pose risk
  • Blood or plasma donation within the past 2 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants follow either an 8-hour restricted eating duration or continue their habitual extended eating duration for 4 weeks while maintaining their usual sleep patterns.

Weekly visits for up to 4 weeks

Trial Site Locations

Total: 1 location

1

Recruiting core Pennington

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

P

Prachi Singh, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Frequently Asked Questions

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