Time-restricted Eating, Appetite and Sleep (SLEEPFAST)

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Appetitive Behavior
• Intervention / Treatment: Behavioral: Time-restricted eating

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile, 8380453
      • Department of Nutrition, University of Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time-restricted eating; 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; Self-selected 10-hour eating window for 2 months
No Intervention: Control; Participants in the Control group must follow their usual diet routine, without any time restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	2 months

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Principal Investigator: Rodrigo Chamorro, Dr, Department of Nutrition, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: sleep quality; appetite regulation; sleep duration; time-restricted eating
• Other Study ID Numbers: TRE-SLEEP-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Published data generated from the study will be available from the leading author, upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No