Effect of Fasting and Refeeding on T-cell Fate

NCT02719899 | Completed

• 2 other identifiers: 16008516-H-0085
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Researchers want to better understand the body s immune response to calorie restriction. To do this, they are asking healthy volunteers to fast for 24 hours. Researchers will test immune response before and after fasting. Objectives: To explore the benefits of calorie restriction on immune health. Eligibility: Healthy volunteers ages 21 to 37 with a body mass index between 22 and 29. Design: Participants will be screened with medical history, physical exam, and blood tests. Participants will visit NIH after an overnight fast. Their baseline immune response will be taken. They will give blood and urine samples. Then they will be given breakfast. This visit will take about 2 hours. Participants will fast (not eat or drink anything except water) for the next 24 hours. They will return to NIH the next morning. Their immune response will be taken. They will give blood and urine samples. Then they will be given breakfast. Their immune response will be taken 3 hours later. They will give a blood sample. This visit will take about 4 hours.

Conditions

Asthma; Inflammation

Keywords

NLRP3 Inflammasome; Sirtuin 3; T-Cell Polarity; Caloric Restriction; Natural History

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the change in TH2 cell cytokine (IL-4, IL-5 and/or IL-13) secretion in response to T-cell differentiation comparing the fasted to the refeeding response.

  The comparisons will be performed using paired two-tailed Student t-tests. Significance will be tested at the 0.05 alpha level in this pilot study

  24 hours

Secondary Outcomes (2)

• To identify if nutrient-load regulates T-Cell differentiation capacity and to test whether this pathway could be investigated as atherapeutic target to blunt/negate the inflammation associated with nutrient-excess associated diseases includin...

  Visit 3, 3hrs post-meal

• Evaluate whether these effects are associated with activation of the Sirt3 and its canonical mitochondrial adaptive programs.

  Visit 3, 3hrs post-meal

Study Arms (1)

1

Healthy Volunteers

Eligibility Criteria

• Age: 21 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

-Males and females between the ages of 21 and 37 @@@-BMI greater than or equal to 22 and less than 30

You may qualify if:

• As this is a pilot study, the age-range and BMI range of subjects will be restricted to potentially reduce metabolic variables associated with a wide age- and BMI-range.
• Males and females between the ages of 21 and 37
• BMI greater than or equal to 22 and less than 30

You may not qualify if:

• Subjects with an acute or chronic illness as per history, on laboratory analysis or due to use of medications
• Subjects taking vitamins or supplements or any medications, except oral contraceptives, within 4 weeks of participation into this study
• BMI less than 22 or greater than or equal to 30
• Female subjects who are pregnant or lactating
• Subjects who have donated blood or participated in another clinical trial involving blood draws in the last 8 weeks
• Subjects who use nicotine products

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Sack MN, Finkel T. Mitochondrial metabolism, sirtuins, and aging. Cold Spring Harb Perspect Biol. 2012 Dec 1;4(12):a013102. doi: 10.1101/cshperspect.a013102.

  PMID: 23209156 BACKGROUND

• Fontana L, Meyer TE, Klein S, Holloszy JO. Long-term calorie restriction is highly effective in reducing the risk for atherosclerosis in humans. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6659-63. doi: 10.1073/pnas.0308291101. Epub 2004 Apr 19.

  PMID: 15096581 BACKGROUND

• Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.

  PMID: 25815989 BACKGROUND

• Han K, Singh K, Rodman MJ, Hassanzadeh S, Wu K, Nguyen A, Huffstutler RD, Seifuddin F, Dagur PK, Saxena A, McCoy JP, Chen J, Biancotto A, Stagliano KER, Teague HL, Mehta NN, Pirooznia M, Sack MN. Fasting-induced FOXO4 blunts human CD4+ T helper cell responsiveness. Nat Metab. 2021 Mar;3(3):318-326. doi: 10.1038/s42255-021-00356-0. Epub 2021 Mar 15.

  PMID: 33723462 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Asthma; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael N Sack, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 25, 2016
• Study Start: April 18, 2016
• Primary Completion: February 24, 2017
• Study Completion: February 24, 2017
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

US (1)