Impact of Intermittent Fasting on Sleep and Quality of Life

NCT06959069 | Recruiting

• 1 other identifier: P2024/515/CCB B4062024000365
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the impact of intermittent fasting on sleep, quality of life and fatigue among healthy volunteers. The main questions aim to answer: Whether intermittent fasting would allow participants to experience an improvement in their sleep quality, duration and latency? Whether intermittent fasting would ameliorate participants' quality of life and reduce chronic fatigue symptoms? Researchers will compare the two most prevailing fasting windows of intermittent diet including an early morning feeding window (8 a.m.-4 p.m.) and a late feeding window (12 p.m.-8 p.m.) to see if there is a difference among these feeding windows on sleep and quality of life. Participants will:

• Be divided into two groups (group A and group B) that will alternate their fasting windows.
• Group A will start with intermittent fasting over a feeding period from 12 p.m. to 8 p.m. for one month, then a two weeks period of usual eating habits (washout period) and finally one month of intermittent fasting with a feeding period from 8 a.m. to 4 p.m.
• Group B will follow intermittent fasting over a feeding period from 8 a.m. to 4 p.m for one month, then a two weeks period of usual eating habits (washout period) and finally one month of intermittent fasting with a feeding period from 12 p.m. to 8 p.m.
• At enrollment, at the end of each month of intermittent fasting and at the end of washout period participants will be asked to complete some questionnaires and will be submitted to anthropometric measurements using impedance scales.
• Participants will be asked to complete an electronic 24 hour recall diary using the Automated Self-Administered 24h Dietary Assessment (ASA24) Tool software once per week every week during study.

Conditions

Sleep Quality; Quality of Life; Fatigue; Intermittent Fasting

Keywords

intermittent fasting; sleep; quality of life; fatigue

Outcome Measures

Primary Outcomes (3)

• Impact of intermittent fasting on sleep

  The primary outcome of this study will be to investigate the impact of intermittent fasting on sleep including sleep quality, efficiency, duration, and sleep latency among healthy individuals. This will be carried out using the Pittsburgh Sleep Quality Index (PSQI) : a standardized self-report questionnaire assessing the subjective sleep quality, sleep efficiency (percentage of time spent in bed actually asleep), sleep duration, and sleep latency (time taken to fall asleep) over the last month. It consists of 19 items, resulting in a total score of 0 to 21. Scores above 5 can be used as an indicator of poor sleep quality.

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

• Impact of intermittent fasting on quality of life

  The second objective will be to explore the impact of intermittent fasting on participants' quality of life using the validated questionnaire Short Form Health 36 (SF-36) that objectively measures quality of life by covering eight domains of health. Sf-36 assesses eight scales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, energy/fatigue, social functioning, general mental health (emotional well-being), and role limitations due to emotional health, measured by 36 questions. All scores are recoded with a maximum score of 100. A higher score indicates a better quality of life.

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

• Impact of intermittent fasting on fatigue

  Another primary outcome that will be explored is the impact of intermittent fasting on symptoms of fatigue. This will be carried out using the Fatigue Assessment Scale (FAS), a 10-item scale assessing symptoms of chronic fatigue. Each item of the FAS is answered using a 5-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Total scores range from 10 to 50 with higher scores indicating higher levels of fatigue.

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

Secondary Outcomes (12)

• Impact of intermittent fasting on physical activity

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

• Effect of intermittent fasting on Body Mass Index

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

• Impact of Intermittent fasting on total energy intake

  All participants will complete the ASA24 24-hour recall diary once per week for the total 10-week duration of the study (10 times in total). The participants will choose the day during the week that they want to recall their diet.

• Effect of intermittent fasting on Muscle Mass

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

• Effect of intermittent fasting on Visceral Mass

  In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)

Study Arms (2)

Intermittent Fasting - Group A

ACTIVE COMPARATOR

Group A will follow intermittent fasting over a feeding period from 12 p.m. to 8 p.m. (known as late feeding window) for one month, then a two weeks period (washout period) that participants will return to their usual eating habits and finally one month of intermittent fasting with a feeding period from 8 a.m. to 4 p.m (early feeding window).

Other: Intermittent Fasting - Late feeding window; Other: Intermittent Fasting - Early feeding window

Intermittent Fasting - Group B

ACTIVE COMPARATOR

Group B will follow intermittent fasting over a feeding period from 8 a.m. to 4 p.m (early feeding window) for one month, then a two weeks period (washout period) that participants will return to their usual eating habits and finally one month of intermittent fasting with a feeding period from 12 p.m. to 8 p.m. (known as late feeding window).

Other: Intermittent Fasting - Late feeding window; Other: Intermittent Fasting - Early feeding window

Interventions

Intermittent Fasting - Late feeding window OTHER

Intermittent fasting is an eating pattern that consists of alternating periods of fasting of varying duration with periods of eating. In the present study, all participants will follow a time-restricted feeding/eating (TRF/E) that restricts all dietary intake to an 8- hour daily eating window. There will be two different feeding periods. The first window will allow a feeding period from12 p.m. to 8 p.m. (late feeding window).

Intermittent Fasting - Group A; Intermittent Fasting - Group B

Intermittent Fasting - Early feeding window OTHER

Intermittent fasting is an eating pattern that consists of alternating periods of fasting of varying duration with periods of eating. In the present study, all participants will follow a time-restricted feeding/eating (TRF/E) that restricts all dietary intake to an 8- hour daily eating window. There will be two different feeding periods. The second window will allow a feeding period from 8 a.m. to 4 p.m (early feeding window).

Intermittent Fasting - Group A; Intermittent Fasting - Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Adult subjects - age: between 18 and 65 years old
• Subjects with a BMI between 18.5 and 29.9 kg/m\^2
• Male and female subjects

You may not qualify if:

• Subjects \< 18 years old
• Subjects with Diabetes Mellitus (type 1 and type 2)
• Pregnant and/or breastfeeding and/or postpartum women
• Underweight subjects (BMI \< 18.5)
• Obese subjects (BMI \> 30)
• Subjects with confirmed sleep disorders (requiring CPAP or sleep medication (sleeping pills))
• Subjects with renal failure (GFR \< 30 ml/min/1.73 m\^2) or liver disorder
• Subjects with serious cardiovascular, respiratory, neurological, or metabolic medical conditions
• Subjects with malignant tumors
• Subjects with a serious mental disorder requiring medication (e.g., antidepressants or anxiolytics)
• Subjects with eating disorders
• Subjects who have undergone major surgery or have been hospitalized due to major medical condition (surgery, stay in intensive care) within the last one year
• Subjects who have lost more than 10% of their body weight within the last one year
• Subjects actively participating in a weight-loss program
• Subjects with alcohol use disorder (maximum 10 standard alcoholic drinks per week, 2 standard alcoholic drinks per day)

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Libre University, Faculty of Human Motor Sciences, Campus Erasme

Brussels, 1070 Anderlecht, Belgium

RECRUITING

Related Publications (5)

• Wei X, Cooper A, Lee I, Cernoch CA, Huntoon G, Hodek B, Christian H, Chao AM. Intermittent Energy Restriction for Weight Loss: A Systematic Review of Cardiometabolic, Inflammatory and Appetite Outcomes. Biol Res Nurs. 2022 Jul;24(3):410-428. doi: 10.1177/10998004221078079. Epub 2022 May 8.

  PMID: 35531785 BACKGROUND

• Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020 Jan 7;31(1):92-104.e5. doi: 10.1016/j.cmet.2019.11.004. Epub 2019 Dec 5.

  PMID: 31813824 BACKGROUND

• Anic K, Schmidt MW, Furtado L, Weidenbach L, Battista MJ, Schmidt M, Schwab R, Brenner W, Ruckes C, Lotz J, Lackner KJ, Hasenburg A, Hasenburg A. Intermittent Fasting-Short- and Long-Term Quality of Life, Fatigue, and Safety in Healthy Volunteers: A Prospective, Clinical Trial. Nutrients. 2022 Oct 10;14(19):4216. doi: 10.3390/nu14194216.

  PMID: 36235868 BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available.

  PMID: 24222017 BACKGROUND

• Kim BH, Joo Y, Kim MS, Choe HK, Tong Q, Kwon O. Effects of Intermittent Fasting on the Circulating Levels and Circadian Rhythms of Hormones. Endocrinol Metab (Seoul). 2021 Aug;36(4):745-756. doi: 10.3803/EnM.2021.405. Epub 2021 Aug 27.

  PMID: 34474513 BACKGROUND

Related Links

• Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue; Intermittent Fasting

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Marianna Arvanitaki, Professor

  Erasme University Hospital, Gastroenterology Department -Libre University

  STUDY DIRECTOR

Central Study Contacts

Marianna Spinou, Medical Doctor

CONTACT

00306939737204; marspinou@med.uoa.gr

Clemence Hochedez, Master of science candidate

CONTACT

00320494185588; clemence.hochedez@ulb.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: At recruitment, all subjects will provide their written informed consent prior to enrolling in the study. Once the subject's consent is obtained, the participants will be randomly assigned to Group A or Group B. The study will last 10 weeks in total, with 4 weeks for each intermittent fasting window, followed by a 2-week "washout" period where the subjects follow their usual diet between each group of 4 weeks intermittent fasting period. For the first month, group A will follow a feeding period from 12 p.m. to 8 p.m. (known as late feeding window) and group B will follow a feeding period from 8 a.m. to 4 p.m. (known as early feeding window). The following 2 weeks both groups will return to their usual eating habits (washout period). For the second month, group A will follow an early feeding window while group B will follow a late feeding window.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 6, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: researchers who provide a methodologically sound proposal

Locations

BE (1)