We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Immun Status Changes Due to Intermittent Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877314
Recruitment Status : Completed
First Posted : May 7, 2021
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ufuk Oguz Idiz, Istanbul Training and Research Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Positive effects of calorie restriction on quality of life and diseases are reported. Intermittent fasting, one of the calorie restriction methods, has been shown to be beneficial for health with many metabolic effects, not just calorie restriction. 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. 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 this study, we aimed to evaluate the conditions of inflammatory markers in peripheral blood before and after intermittent fasting period in overweight volunteers with a Body Mass Index between 25 and 30. Volunteers will have intermittent fasting for 3 weeks, which conforms to the 16-hour fasting and 8-hour meal format.

Condition or disease Intervention/treatment Phase
Intermittent Fasting Other: Intermittent fasting Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cytokine levels before and after intermittent fasting period for 3 weeks
Masking: None (Open Label)
Masking Description: Measuring the level of IL1, IL6, TNFα, IL10 cytokines before and after the 3 weeks intermittent fasting period for 30 overweight volunteers
Primary Purpose: Diagnostic
Official Title: The Effect of Intermittent Fasting on Immune System
Actual Study Start Date : April 13, 2021
Actual Primary Completion Date : May 5, 2021
Actual Study Completion Date : June 15, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intermittent fasting Other: Intermittent fasting
30 overweight male volunteers who will have 3 weeks intermittent fasting which has 16 hours fasting and 8 hours eating in a day period.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cytokine levels [ Time Frame: 3 weeks ]
    IL1, IL6, TNFα, IL10 cytokine levels


Secondary Outcome Measures :
  1. Demographic values [ Time Frame: 3 weeks ]
    Weight as kilograms, Height as meters


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Hormonal factors could affect cytokine values over time
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877314


Locations
Layout table for location information
Turkey
Istanbul Training and Research Hospital
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ufuk O Idiz, Assoc.Prof. Istanbul Training and Research Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Ufuk Oguz Idiz, Assoc. Prof. MD, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04877314    
Other Study ID Numbers: Intermittent fasting immune
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: If the study complete, we could share

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ufuk Oguz Idiz, Istanbul Training and Research Hospital:
Cytokine
Intermittent fasting