The Immun Status Changes Due to Intermittent Fasting

June 1, 2022 updated by: Ufuk Oguz Idiz, Istanbul Training and Research Hospital

The Effect of Intermittent Fasting on Immune System

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34098
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine levels
Time Frame: 3 weeks
IL1, IL6, TNFα, IL10 cytokine levels
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic values
Time Frame: 3 weeks
Weight as kilograms, Height as meters
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ufuk O Idiz, Assoc.Prof., Istanbul Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

May 5, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Intermittent fasting immune

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

If the study complete, we could share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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