Effect of Fasting on the NLRP3 Inflammasome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-21

Study Completion Date

2021-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background:

\- Restricting calories can help a person reduce risk factors for heart disease. Researchers have found that not eating or drinking anything but water for 24 hours prevents the activation of a component of the immune system, called the inflammasome. The inflammasome is associated with the development of diabetes and heart disease. Researchers want to learn more about the body s response to fasting.

Objective:

\- To explore the benefits of calorie restriction on heart health.

Eligibility:

\- Healthy adults ages 21 32 with a body mass index between 26 and 29.

Design:

* Participants will be screened with a medical history, physical exam and blood test.
* Participants will not eat or drink after 10 p.m. before their first visit.
* Participants have breakfast at the clinic. The breakfast will be about 500 calories. Then they will not eat or drink (except water) for 24 hours.
* Participants will return to the clinic the next morning. They will have blood drawn. Then they will have breakfast. Blood will be drawn again at 1 hour and 3 hours after the meal.
* Blood and urine tests at the end of the fast and following the meals will be done to confirm that participants have fasted for the full 24-hour period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Fasting and Refeeding on T-cell Fate

NCT02719899

Asthma Inflammation

COMPLETED

Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?

NCT01964118

Obesity Overweight

COMPLETED NA

Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

NCT04353869

Glutamine Diabetic Cardiovascular Complications

COMPLETED

A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases

NCT03193177

Fasting Chronic Disease Autoimmune Diseases +6 more

COMPLETED

The Fasting Study - Unraveling the Mechanistic Effects of Prolonged Fasting in Humans.

NCT03757767

Fasting Adipose Tissue Clinical Trial +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A caloric restricted diet has numerous health effects including the reduction in numerous cardiovascular disease risk factors. The cellular programs activated by caloric restriction are similarly turned on in preclinical studies in response to a 24-hour fast. We have found that a beneficial effect of a 24-hour fasting blunts the activation of a component of the immune system, termed the inflammasome, which is associated with the development of diabetes and atherosclerosis. We would like to study the inflammasome in human blood cells to evaluate whether the beneficial immune effects of fasting/caloric restriction are operational in humans. Blood samples to test the immune response will be collected in subjects after a fixed caloric meal and in response to a 24-hour fast (water intake will not be restricted). The objective of this pilot study is to identify if these immune adaptive pathways can be activated in human subjects as a possible readout to test whether this pathway could be investigated as a therapeutic target to blunt/negate the inflammation associated with nutrient-excess associated diseases such as diabetes and/or atherosclerosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease Inflammatory Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Males and females between the ages of 21 and 37

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 between 23.5 and 29

Exclusion Criteria

* 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 \<23.5 or \>29
* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No