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Behavioural Intervention

Time Restricted Eating for Sleep Deprivation (CRISP Trial)

N/A
Recruiting
Led By Prachi Singh, PhD
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18-45 years
Be between 18 and 65 years old
Must not have
Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score >10)
Recent changes in body weight (≥5%) within 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate if restricting eating hours can improve cardiovascular and metabolic health in people who don't get enough sleep.

Who is the study for?
This trial is for adults aged 18-45 with a BMI of 25-35 who usually sleep less than 6.5 hours and eat over a span of more than 14 hours per day. They should not have chronic health issues like hypertension or diabetes, but those with prehypertension or prediabetes may join if they agree to use birth control (if applicable) and can follow the study's eating schedule.
What is being tested?
The study tests whether limiting eating to an 8-hour window each day can improve heart health and blood sugar levels in people who don't get much sleep. Participants will maintain their normal diet, sleep, and exercise routines while following this time-restricted eating plan.
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects might include hunger outside of the allowed eating times, potential changes in energy levels or mood swings due to alterations in usual meal patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I often feel very sleepy during the day.
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I have lost or gained more than 5% of my body weight in the last 3 months.
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I am currently experiencing severe depression or have thoughts of suicide.
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I do not have uncontrolled depression, anxiety, psychosis, or bipolar disorder.
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I have severe insomnia or sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in 24h mean arterial blood pressure (MAP)
Change in insulin resistance
Secondary study objectives
Change in 24h systolic blood pressure (SBP)
Change in postprandial glycemic excursion
Other study objectives
Change in clock time for dim light melatonin offset
Change in clock time for dim light melatonin onset
Change in melatonin area under the curve (AUC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eating (TRE)Experimental Treatment1 Intervention
Subjects randomized to this arm will be asked to follow an 8h eating duration/day for 4 weeks.
Group II: Habitual eating durationActive Control1 Intervention
Subjects randomized to this arm will be asked to continue habitual eating duration of \>14h/day for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating (TRE)
2022
N/A
~30

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
309 Previous Clinical Trials
180,032 Total Patients Enrolled
1 Trials studying Sleep Deprivation
300 Patients Enrolled for Sleep Deprivation
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,231 Total Patients Enrolled
12 Trials studying Sleep Deprivation
5,109 Patients Enrolled for Sleep Deprivation
Prachi Singh, PhDPrincipal InvestigatorPennington Biomedical Research Institute
3 Previous Clinical Trials
132 Total Patients Enrolled
~67 spots leftby Jun 2028
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