Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485037
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-10-24
Brief Title:
Time-restricted Eating Appetite and Sleep
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Effect of Time-restricted Eating on Appetite and Sleep in Adults With Poor Sleeping Habits
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEPFAST
Brief Summary:
The goal of this clinical trial is to learn about the effect of time-restricted eating TRE to 10 hours per day on the regulation of appetite the desire to eat and the quality and duration of nocturnal sleep in adults with normal weight and short sleep duration andor habitual poor quality sleep
The main questions it aims to answer are 1 How does a time-restricted eating protocol affect appetite and desire to eat and 2 How does a time-restricted eating protocol affect nighttime sleep duration and quality Participants will be asked to follow a TRE protocol on which they must restrict their eating to a self-selected time window of 10 hours per day but with mandatory fasting from 11 pm to 6 am for 2 months Researchers will compare the intervention with a control group in which the participants should follow their usual diet without any time restriction to see if the intervention decreases appetite and desire to eat improves the quality and increases sleep duration
The main questions it aims to answer are 1 How does a time-restricted eating protocol affect appetite and desire to eat and 2 How does a time-restricted eating protocol affect nighttime sleep duration and quality Participants will be asked to follow a TRE protocol on which they must restrict their eating to a self-selected time window of 10 hours per day but with mandatory fasting from 11 pm to 6 am for 2 months Researchers will compare the intervention with a control group in which the participants should follow their usual diet without any time restriction to see if the intervention decreases appetite and desire to eat improves the quality and increases sleep duration
Detailed Description:
Time-restricted eating TRE restricts the time to consume food during the day establishing a feeding window thus extending the fasting period It has been suggested that TRE may regulate appetite and sleep quality even though the evidence is equivocal for these last two aspects This study aims to determine the effect of TRE to 10 hours per day on regulating appetite the desire to eat and the quality and duration of nocturnal sleep in normal-weight adults with short-duration andor habitual poor-quality sleep
The study sample will be composed of at least 24 participants randomly assigned to an intervention TRE or no-intervention Control group Participants will be recruited in the Santiago Metropolitan region near the Faculty of Medicine of the University of Chile Independencia commune through an open call to participate through flyers and on social networks The groups being randomly compared are i TRE intervention group in which participants must restrict their eating to a time window of 10 hours per day with mandatory fasting from 11 pm to 6 am and ii Control no-intervention group in which the participants should follow their usual diet without any time restriction Both groups will be evaluated before during and after 2 months
In both groups the following main parameters will be evaluated i appetite and satiety feelings through visual analog scales and the intense desire to eat through a Food Craving inventory ii the quality of habitual sleep during the last month through the Pittsburgh Sleep Quality Index and nighttime sleep duration through 7-days actigraphy recordings iii diet composition and quality through 24-h recall Measurements of anthropometry and body fat will also be implemented
The study sample will be composed of at least 24 participants randomly assigned to an intervention TRE or no-intervention Control group Participants will be recruited in the Santiago Metropolitan region near the Faculty of Medicine of the University of Chile Independencia commune through an open call to participate through flyers and on social networks The groups being randomly compared are i TRE intervention group in which participants must restrict their eating to a time window of 10 hours per day with mandatory fasting from 11 pm to 6 am and ii Control no-intervention group in which the participants should follow their usual diet without any time restriction Both groups will be evaluated before during and after 2 months
In both groups the following main parameters will be evaluated i appetite and satiety feelings through visual analog scales and the intense desire to eat through a Food Craving inventory ii the quality of habitual sleep during the last month through the Pittsburgh Sleep Quality Index and nighttime sleep duration through 7-days actigraphy recordings iii diet composition and quality through 24-h recall Measurements of anthropometry and body fat will also be implemented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None