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Effect of Fasting on the Asthma Inflammasome

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ClinicalTrials.gov Identifier: NCT02471300
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.

Condition or disease
Asthma

Detailed Description:
The NLRP3 inflammasome is part of the innate immune system that can be activated by atherosclerosis, gout and diabetes (sterile inflammation). As mitochondrial signaling can trigger the NLRP3 inflammasome, we initially proposed that fasting, via a nutrient-sensing mitochondrial program, would dampen this innate immune program. Our preliminary data shows that a 24-hour fasting does blunt NLRP3 inflammasome activation in healthy young individuals. Interestingly, this inflammasome program has been implicated in the pathophysiology of bronchoreactivity linked to asthma and intermittent fasting has been found to reduce disease exacerbations in asthmatic patients. The objective of this protocol will extend our investigations, from what we are finding in young control normal volunteers, to enable us to investigate stable mild-moderate asthmatic subjects to determine whether fasting can blunt inflammasome activation and assess whether this transient nutrient-deprivation maneuver can improve airflow. Blood samples and pulmonary function testing to assay the immune response and bronchoreactivity will be performed in subjects in response to a 24-hour fast (water intake will not be restricted) followed by re-testing 3 hours after a fixed caloric meal. The objective of this pilot study is to identify if these immune adaptive pathways can be subdued in human subjects with a known inflammasome linked disease. Additionally, this study may enable us to identify a potential therapeutic pathway to blunt/negate inflammation associated with nutrient-excess associated bronchoreactivity of asthma.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study to Evaluate the Effect of Fasting on the Asthma Inflammasome
Actual Study Start Date : August 26, 2015
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
1
stable mild-moderate asthmatic subjects



Primary Outcome Measures :
  1. Change in IL-1-beta secretion in response to inflammasome stimulation in PBMCs comparing the fasted response to the fed response [ Time Frame: 24 hours ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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@@@@@@
Criteria
  • INCLUSION CRITERIA:
  • 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

EXCLUSION CRITERIA:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471300


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Michael N Sack, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
Publications:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02471300    
Other Study ID Numbers: 150136
15-H-0136
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 6, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Asthma
Inflammasome
Fasting
Airflow Obstruction
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases