Effect of Fasting on the Asthma Inflammasome

NCT02471300 | Completed

• 2 other identifiers: 15013615-H-0136
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Research shows that restricting calories has a positive effect on immune cell health in healthy people. Researchers want to learn if it will help people with asthma. They want to better understand how the body s immune response and lung function responds to short-term calorie restriction. For this, they want people to fast (no food or drink except water) for 24 hours. Objective: To explore the benefits of calorie restriction in people with asthma. Eligibility: Healthy people ages 18 to 60 who have a history consistent with asthma and prior documentation of airflow obstruction or wheezing. Design:

• Participants who have taken part in asthma research at NIH will be screened with a telephone interview. All other participants will have a medical history, blood tests, and physical exam.
• Eligible participants will return to the NIH Clinical Center one morning for 2 hours. They will be fed breakfast. They may have blood and urine tests.
• Participants will then fast for 24 hours.
• Participants will return to the Clinical Center the next morning for 4 hours. They will have blood drawn. They will eat breakfast and then repeat blood draws 2.5 hours later. They will have a urine test.
• Blood and urine tests will be done at the end of the fast and after the meals to confirm that the participant fasted for the full 24-hour period.
• Participants will have lung function tests and exhaled gas measurements. A machine will measure the volume of air they can breathe out. Some gases in the breath increase with inflammation. Participants will breathe into a machine that analyzes the gases in their breath.

Conditions

Asthma

Keywords

Asthma; Inflammasome; Fasting; Airflow Obstruction

Outcome Measures

Primary Outcomes (1)

• Change in IL-1-beta secretion in response to inflammasome stimulation in PBMCs comparing the fasted response to the fed response

  Determine whether the NLRP3 inflammasome is blunted by a 24-hour fast in PBMC s in subjects with mild to moderate asthma.Initiate 24-hour fast with the exception of drinking water and use of asthma medications until midnight. Patients will be asked to hold their asthma medications after midnight. Fasting research labs to study the inflammasome and Fed State Research Labs to study the inflammasome.

  24 hours

Study Arms (1)

1

stable mild-moderate asthmatic subjects

Eligibility Criteria

• Age: 18 Years - 60 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 18 and 60@@@-Asthmatic subjects will have a history consistent with asthma, be on chronic asthma therapy and have prior documentation of reversible airflow obstruction based upon either a positive response to an inhaled bronchodilator or a positive methacholine broncho-provocation challenge test@@@@@@

You may qualify if:

• Males and females between the ages of 18 and 60
• Asthmatic subjects will have a history consistent with asthma, be on chronic asthma therapy and have prior documentation of reversible airflow obstruction based upon either a positive response to an inhaled bronchodilator or a positive methacholine bronchoprovocation challenge test

You may not qualify if:

• Subjects with concurrent acute illness or other chronic illnesses associated with inflammation including diabetes requiring medical management.
• 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.
• Medical condition identified by screening bloodwork that would preclude safe participation or valid data collection.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Besnard AG, Guillou N, Tschopp J, Erard F, Couillin I, Iwakura Y, Quesniaux V, Ryffel B, Togbe D. NLRP3 inflammasome is required in murine asthma in the absence of aluminum adjuvant. Allergy. 2011 Aug;66(8):1047-57. doi: 10.1111/j.1398-9995.2011.02586.x. Epub 2011 Mar 28.

  PMID: 21443539 BACKGROUND

• Kim SR, Kim DI, Kim SH, Lee H, Lee KS, Cho SH, Lee YC. NLRP3 inflammasome activation by mitochondrial ROS in bronchial epithelial cells is required for allergic inflammation. Cell Death Dis. 2014 Oct 30;5(10):e1498. doi: 10.1038/cddis.2014.460.

  PMID: 25356867 BACKGROUND

• Kim HY, Lee HJ, Chang YJ, Pichavant M, Shore SA, Fitzgerald KA, Iwakura Y, Israel E, Bolger K, Faul J, DeKruyff RH, Umetsu DT. Interleukin-17-producing innate lymphoid cells and the NLRP3 inflammasome facilitate obesity-associated airway hyperreactivity. Nat Med. 2014 Jan;20(1):54-61. doi: 10.1038/nm.3423. Epub 2013 Dec 15.

  PMID: 24336249 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Asthma; Fasting

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Michael N Sack, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 15, 2015
• Study Start: August 26, 2015
• Primary Completion: March 6, 2017
• Study Completion: January 27, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (1)