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Completed

NCT Number: NCT06485037

Time-restricted Eating, Appetite and Sleep

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.

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Key information

Conditions

Sleep Appetitive Behavior Behavior Behavior, Animal Dyssomnias Fasting Feeding Behavior Intermittent Fasting Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, University of Chile

Santiago, Santiago Metropolitan, 8380453, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted eating

Behavioral

Self-selected 10-hour eating window for 2 months

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

Secondary outcomes

  1. Craving for foods as assessed by the Food Craving inventory

    Time frame: 2 months

    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. Energy intake as assessed by 24-hour dietary recall

    Time frame: 2 months

    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).

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Effect of Time-restricted Eating on Appetite and Sleep in Adults With Poor Sleeping Habits

Acronym: SLEEPFAST

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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