NCT06959069 Impact of Intermittent Fasting on Sleep and Quality of Life
| NCT ID | NCT06959069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université Libre de Bruxelles |
| Condition | Sleep Quality |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-03-17 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Subjects with substance use disorder * Subjects unable to provide informed consent * Subjects who do not participate simultaneously in another clinical trial
Contact & Investigator
Marianna Arvanitaki, Professor
STUDY DIRECTOR
Erasme University Hospital, Gastroenterology Department -Libre University
Frequently Asked Questions
Who can join the NCT06959069 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Sleep Quality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06959069 currently recruiting?
Yes, NCT06959069 is actively recruiting participants. Contact the research team at marspinou@med.uoa.gr for enrollment information.
Where is the NCT06959069 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06959069 clinical trial?
NCT06959069 is sponsored by Université Libre de Bruxelles. The principal investigator is Marianna Arvanitaki, Professor at Erasme University Hospital, Gastroenterology Department -Libre University. The trial plans to enroll 36 participants.