The Immun Status Changes Due to Intermittent Fasting

NCT04877314 | Completed DMC

• 1 other identifier: Intermittent fasting immune
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting

Keywords

Cytokine; Intermittent fasting

Outcome Measures

Primary Outcomes (1)

• Cytokine levels

  IL1, IL6, TNFα, IL10 cytokine levels

  3 weeks

Secondary Outcomes (1)

• Demographic values

  3 weeks

Study Arms (1)

Intermittent fasting

EXPERIMENTAL

Other: Intermittent fasting

Interventions

Intermittent fasting OTHER

30 overweight male volunteers who will have 3 weeks intermittent fasting which has 16 hours fasting and 8 hours eating in a day period.

Intermittent fasting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Hormonal factors could affect cytokine values over time
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bady mass index should be between 25-30
• Male

You may not qualify if:

• Diabetes patients,
• Immune deficiency history,
• Cancer patients,
• Individuals who did not agree to participate in the study

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 9309105 BACKGROUND

• Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.

  PMID: 27885007 BACKGROUND

• 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.

  PMID: 30442801 BACKGROUND

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Ufuk O Idiz, Assoc.Prof.

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Measuring the level of IL1, IL6, TNFα, IL10 cytokines before and after the 3 weeks intermittent fasting period for 30 overweight volunteers
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Model Details: Cytokine levels before and after intermittent fasting period for 3 weeks

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 7, 2021
• Study Start: April 13, 2021
• Primary Completion: May 5, 2021
• Study Completion: June 15, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)