- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877314
The Immun Status Changes Due to Intermittent Fasting
The Effect of Intermittent Fasting on Immune System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In a 1997 article by Weindruch and Sohal, they reported that reducing food availability (calorie restriction) throughout life has significant effects on aging and lifespan in animals. There are many modalities for calorie restriction, one of which is intermittent fasting. Intermittent fasting involves having little or no energy intake during a certain period of the day, then free intake of energy for the rest of the day. Some of the modalities applied in this context can be listed as 12 hours fasting-12 hours eating, 16 hours fasting-8 hours eating, 20 hours fasting-4 hours eating. Studies in animals and humans show that most of the health benefits of intermittent fasting are not just the result of decreased free radical production or weight loss. Instead, intermittent fasting elicits cellular responses that can adapt to improve glucose regulation between and within organs, increase stress resistance, and suppress inflammation. During intermittent fasting, cells activate pathways that increase their defenses against oxidative and metabolic stress and remove or repair damaged molecules.Preclinical studies show the disease-modifying effects of intermittent fasting in animal models on a wide variety of chronic disorders, including obesity, diabetes, cardiovascular disease, cancers, and neurodegenerative brain diseases . Periodic opening and closing of metabolism with intermittent fasting not only provides the ketones necessary for cells to use during the fasting period, but also elicits highly regulated systemic and cellular responses to increase mental and physical performance and disease resistance.
There are very few studies evaluating the effects of intermittent fasting on the immune system, and only TNFα, IL6 and IL10 cytokines were evaluated in these studies to evaluate the immune system. In one of these studies, it was reported that proinflammatory cytokines of TNFα, IL6, which were measured after intermittent fasting for 30 days for 14 hours, decreased significantly.
In this study, the investigators aimed to evaluate the effect of 16-hour fasting and 8-hour intermittent fasting application on overweight volunteers with a Body Mass Index of 25-30 for inflammatory markers in peripheral blood .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34098
- Istanbul Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bady mass index should be between 25-30
- Male
Exclusion Criteria:
- Diabetes patients,
- Immune deficiency history,
- Cancer patients,
- Individuals who did not agree to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intermittent fasting
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30 overweight male volunteers who will have 3 weeks intermittent fasting which has 16 hours fasting and 8 hours eating in a day period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cytokine levels
Time Frame: 3 weeks
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IL1, IL6, TNFα, IL10 cytokine levels
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic values
Time Frame: 3 weeks
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Weight as kilograms, Height as meters
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3 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Ufuk O Idiz, Assoc.Prof., Istanbul Training and Research Hospital
Publications and helpful links
General Publications
- Weindruch R, Sohal RS. Seminars in medicine of the Beth Israel Deaconess Medical Center. Caloric intake and aging. N Engl J Med. 1997 Oct 2;337(14):986-94. doi: 10.1056/NEJM199710023371407. No abstract available.
- Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
- Di Francesco A, Di Germanio C, Bernier M, de Cabo R. A time to fast. Science. 2018 Nov 16;362(6416):770-775. doi: 10.1126/science.aau2095.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Intermittent fasting immune
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intermittent Fasting
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University of BariCompleted
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Okan UniversityEnrolling by invitation
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Josip Juraj Strossmayer University of OsijekCompleted
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University of the PunjabCompleted
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University of BariCompleted
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University of UtahTerminatedCancer PreventionUnited States
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Clinical Trials on Intermittent fasting
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Ohio State UniversityNational Psoriasis FoundationCompletedPsoriasis | Psoriatic ArthritisUnited States
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Ministry of Health, MalaysiaCompletedObesity | Intermittent FastingMalaysia
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Washington University School of MedicineCompletedRelapsing Remitting Multiple SclerosisUnited States
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Charite University, Berlin, GermanyWestfälische Wilhelms-Universität MünsterCompleted