SleepSLEEPFASTNCT06485037
Time-restricted Eating, Appetite and Sleep
A study testing Time-restricted eating in people with Sleep and Appetitive Behavior, run by University of Chile at 1 site in Chile.
Trial 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 and/or habitual poor quality sleep. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Appetitive Behavior
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 11 Aug 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young (age between 18 to 45 years)
- Healthy adults
- Both women and men
- Body-mass index between 18.5 to 24.9 kg/m2
- Report sleeping less than 7 hours per night and/or who have poor sleep quality.
Who cannot join
- Night shift workers
- Patients with psychiatric disorders
- Patients with neurological diseases
- Patients with uncontrolled thyroid disease
- Lactating and pregnant women
- Patients with type-1 or type-2 diabetes
Show all 10Show fewer
- Persons with high blood pressure or hypertension
- Patients with uncontrolled dyslipidemia
- Patients with sleep disorders
- Persons who perform intense physical exercise more than 3 times a week
Trial locations and contacts
1 site in 1 country.
Chile1 site
Department of Nutrition, University of Chile
Santiago, Santiago Metropolitan, 8380453
About this study
Official title: Effect of Time-restricted Eating on Appetite and Sleep in Adults With Poor Sleeping Habits
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 and/or 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 p.m. to 6 a.m.) 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.
Read the 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 and/or 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 p.m. to 6 a.m.; 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.
- Conditions
- Sleep, Appetitive Behavior
- Being tested
- Time-restricted eating
- Keywords
- time-restricted eating, sleep duration, sleep quality, appetite regulation
- Medical subject headings
- Appetitive Behavior, Intermittent Fasting, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Self-selected 10-hour eating window for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | Participants in the TRE group must restrict their eating to a time window of 10 hours per day, with mandatory fasting from 11 p.m. to 6 a.m. Receives: Behavioral: Time-restricted eating |
| Control | No intervention | Participants in the Control group must follow their usual diet routine, without any time restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite feeling as assessed by a Visual Analog Scale
A visual analog scale was used to assess appetite feeling. Each participant rates their subjective feelings of appetite (before and after completion of the study) using a 100 mm visual analog scale, with endpoints indicating from "not at all" (0 mm) to "extremely" (100 mm).
Measured: 2 months
Satiety feeling as assessed by a Visual Analog Scale
A visual analog scale was used to assess satiety feeling. Each participant rates their subjective feelings of satiety (before and after completion of the study) using a 100 mm visual analog scale, with endpoints indicating from "not at all" (0 mm) to "extremely" (100 mm).
Measured: 2 months
Sleep quality as assessed by the Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The PSQI is a 19-item questionnaire evaluating subjective sleep quality over the previous month. Each participant rated each of the 19 questions (before and after completion of the study), and the questions were combined into 7 clinically-derived component scores. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality. Sleep quality score was also categorized as good sleep quality (a global score of less than 5 points) and poor sleep quality (a global score ≥ 5 points).
Measured: 2 months
Sleep duration as assessed by actigraphy
The actigraphy technique measured habitual sleep duration and sleep pattern. Each participant used the Actiwatch®64 (Respironics Mini Mitter Company, Inc.) actigraph for 7 consecutive days on the non-right-handed wrist (before and after completion of the study). The mean total sleep duration (in minutes) is obtained for the recording days.
Measured: 2 months
Secondary outcomes (2)
Craving for foods as assessed by the Food Craving inventory
The Food craving inventory assessed the intense desire (craving) to eat a food. Each participant rated their subjective craving for specific foods, scored from 0 to 4 (where 0 = never; 1 = rarely; 2 = sometimes; 3 = often; and 4 = always/almost every day) according to the strength of the craving. Foods are grouped into four groups: high-fat foods, sweets, carbohydrates/starches, and fast-food fats. A global craving score and four food-specific subscores were obtained.
Measured: 2 months
Energy intake as assessed by 24-hour dietary recall
A 24-hour dietary recall (24hDR) was used to assess each participant's dietary intake (before and after completion of the study). The 24hDR was applied to each participant. Diet composition was obtained from the USDA National Nutrient Database for Standard Reference and a local (Chilean) database. The total daily energy (expressed as kcal/day) and macronutrient (protein, carbohydrate, and fat; expressed as g/day) intake was obtained through the software Food Processor SQL® (ESHA Research, Salem, OR, USA).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start11 Aug 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized, controlled experimental study. The recruited participants will be randomized to follow one of two groups: i) TRE, during which the participants will have to restrict the daily time allocated to eating to a window of 10 hours per day but without any other diet modification (e.g., types of food or amount of energy consumed). The fasting period of participants assigned to this intervention must include between 11 p.m. and 6 a.m. Each participant can freely choose the starting time of their eating window. If a participant needs to make modifications to the start time of her feeding window, he/she may do so only once during the study, and the research team must be informed; ii) Control, during which the participants must continue with their usual eating pattern, without making any changes. The duration of the intervention will be 8 weeks. Randomization will be done using computer-generated random numbers.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo Chamorro, Dr, Principal investigator, Department of Nutrition, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485037
- Sponsor's protocol ID
- TRE-SLEEP-2022
- Acronym
- SLEEPFAST
- Status last verified
- May 2023
- First submitted
- 24 Oct 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Published data generated from the study will be available from the leading author, upon reasonable request.
Publications
Beaumont A, Farias R, Fernandez W, Lizama C, Gonzalez J, Villar A, Varady KA, Peirano P, Chamorro R. Time-restricted eating improves appetite regulation and sleep characteristics in adults with poor sleep quality. Clin Nutr. 2025 Jul;50:66-74. doi: 10.1016/j.clnu.2025.04.028. Epub 2025 May 2.
PubMed 40373727
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-restricted Eating on Appetite and Sleep in Adults With Poor Sleeping Habits
- ClinicalTrials.gov ID
- NCT06485037
- Acronym / sponsor ID
- SLEEPFAST / TRE-SLEEP-2022
- Conditions
- Sleep, Appetitive Behavior
- Keywords
- time-restricted eating, sleep duration, sleep quality, appetite regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and/or 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 p.m. to 6 a.m.) 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 and/or 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 p.m. to 6 a.m.; 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a randomized, controlled experimental study. The recruited participants will be randomized to follow one of two groups: i) TRE, during which the participants will have to restrict the daily time allocated to eating to a window of 10 hours per day but without any other diet modification (e.g., types of food or amount of energy consumed). The fasting period of participants assigned to this intervention must include between 11 p.m. and 6 a.m. Each participant can freely choose the starting time of their eating window. If a participant needs to make modifications to the start time of her feeding window, he/she may do so only once during the study, and the research team must be informed; ii) Control, during which the participants must continue with their usual eating pattern, without making any changes. The duration of the intervention will be 8 weeks. Randomization will be done using computer-generated random numbers.
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eatingParticipants in the TRE group must restrict their eating to a time window of 10 hours per day, with mandatory fasting from 11 p.m. to 6 a.m. |
| Control | No intervention | –Participants in the Control group must follow their usual diet routine, without any time restriction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Young (age between 18 to 45 years)
- Healthy adults
- Both women and men
- Body-mass index between 18.5 to 24.9 kg/m2
- Report sleeping less than 7 hours per night and/or who have poor sleep quality.
Key exclusion criteria (10 listed)
- Night shift workers
- Patients with psychiatric disorders
- Patients with neurological diseases
- Patients with uncontrolled thyroid disease
- Lactating and pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingSelf-selected 10-hour eating window for 2 months | Behavioural | Time-restricted eating |
Primary outcome
Appetite feeling as assessed by a Visual Analog Scale
Time frame: 2 months
A visual analog scale was used to assess appetite feeling. Each participant rates their subjective feelings of appetite (before and after completion of the study) using a 100 mm visual analog scale, with endpoints indicating from "not at all" (0 mm) to "extremely" (100 mm).
Satiety feeling as assessed by a Visual Analog Scale
Time frame: 2 months
A visual analog scale was used to assess satiety feeling. Each participant rates their subjective feelings of satiety (before and after completion of the study) using a 100 mm visual analog scale, with endpoints indicating from "not at all" (0 mm) to "extremely" (100 mm).
Sleep quality as assessed by the Pittsburgh Sleep Quality Index
Time frame: 2 months
The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The PSQI is a 19-item questionnaire evaluating subjective sleep quality over the previous month. Each participant rated each of the 19 questions (before and after completion of the study), and the questions were combined into 7 clinically-derived component scores. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality. Sleep quality score was also categorized as good sleep quality (a global score of less than 5 points) and poor sleep quality (a global score ≥ 5 points).
Sleep duration as assessed by actigraphy
Time frame: 2 months
The actigraphy technique measured habitual sleep duration and sleep pattern. Each participant used the Actiwatch®64 (Respironics Mini Mitter Company, Inc.) actigraph for 7 consecutive days on the non-right-handed wrist (before and after completion of the study). The mean total sleep duration (in minutes) is obtained for the recording days.
2 secondary outcomes
Craving for foods as assessed by the Food Craving inventory
Time frame: 2 months
Energy intake as assessed by 24-hour dietary recall
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 40373727Beaumont A, Farias R, Fernandez W, Lizama C, Gonzalez J, Villar A, Varady KA, Peirano P, Chamorro R. Time-restricted eating improves appetite regulation and sleep characteristics in adults with poor sleep quality. Clin Nutr. 2025 Jul;50:66-74. doi: 10.1016/j.clnu.2025.04.028. Epub 2025 May 2.
- Individual participant dataSharing planned: No. Published data generated from the study will be available from the leading author, upon reasonable request.
Related trials for Sleep
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Chamorro, Dr principal investigator
Department of Nutrition, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Sleep and Appetitive Behavior, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite feeling as assessed by a Visual Analog Scale (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.