Time-restricted Eating, Appetite and Sleep

NCT06485037 | Completed DMC

• 1 other identifier: TRE-SLEEP-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sleep; Appetitive Behavior

Keywords

time-restricted eating; sleep duration; sleep quality; appetite regulation

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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.

  2 months

Secondary Outcomes (2)

• Craving for foods as assessed by the Food Craving inventory

  2 months

• Energy intake as assessed by 24-hour dietary recall

  2 months

Study Arms (2)

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.

Behavioral: Time-restricted eating

Control

NO INTERVENTION

Participants in the Control group must follow their usual diet routine, without any time restriction

Interventions

Time-restricted eating BEHAVIORAL

Self-selected 10-hour eating window for 2 months

Time-restricted eating

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Department of Nutrition, University of Chile

Santiago, Santiago Metropolitan, 8380453, Chile

Location

Related Publications (1)

• 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.

  PMID: 40373727 DERIVED

MeSH Terms

Conditions

Appetitive Behavior; Intermittent Fasting; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Fasting; Feeding Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Rodrigo Chamorro, Dr

  Department of Nutrition, University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: July 3, 2024
• Study Start: August 11, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 3, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)