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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 weeks

Awards & highlights

CRISP Trial 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.Check my eligibility

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.See study design

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.

CRISP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 45 years old.

CRISP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in 24h mean arterial blood pressure (MAP)

Change in insulin resistance

Secondary outcome measures

Change in 24h systolic blood pressure (SBP)

Change in postprandial glycemic excursion

Other outcome measures

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)

CRISP 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

305 Previous Clinical Trials

181,936 Total Patients Enrolled

1 Trials studying Sleep Deprivation

300 Patients Enrolled for Sleep Deprivation

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

3,840 Previous Clinical Trials

47,852,024 Total Patients Enrolled

11 Trials studying Sleep Deprivation

4,709 Patients Enrolled for Sleep Deprivation

Prachi Singh, PhDPrincipal InvestigatorPennington Biomedical Research Institute

3 Previous Clinical Trials

132 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over 45 years of age eligible for this trial?

"This research trial has outlined that only those aged 18 to 45 are eligible for participation. However, there are 6 clinical trials available for minors and 12 specifically designed for seniors above the age of 65."

Answered by AI

What criteria must a person meet to be accepted as a participant of this research?

"Eligibility for this study demands that applicants be aged 18-45 and suffer from sleep deprivation. The trial is seeking 100 enrollees in total."

Answered by AI

Are participants currently being accepted for this research endeavor?

"According to the clinicaltrials.gov page, this medical trial is not presently accepting candidates. The study was initially published on October 4th 2023 and amended lastly on September 30th of that same year. However, there are 42 other trials recruiting at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Prachi Singh 2023. "Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06070194.

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