NCT02471300

Effect of Fasting on the Asthma Inflammasome

Completed Last updated 1 February 2021

What this trial tests

trial in Asthma in 19 participants. Completed in 27 January 2021.

Timeline

26 August 2015

Primary endpoint
6 March 2017

27 January 2021

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	19
Start date	26 August 2015
Primary completion	6 March 2017
Estimated completion	27 January 2021
Sites	1 location across United States

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 60, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
   Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
2. A Pilot Study To Investigate the Immune-Modulatory Effects of Fasting in Steroid-Naive Mild Asthmatics.
   Han K, Nguyen A, Traba J, Yao X, et al · · 2018 · cited 26× · PMID 30021766 · DOI 10.4049/jimmunol.1800585
3. Functional Role of Inflammasome Activation in a Subset of Obese Nonsmoking Patients with Severe Asthma.
   Ruggeri P, Caramori G. · · 2019 · cited 4× · PMID 30908928 · DOI 10.1164/rccm.201903-0667ed