- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02719899
Effect of Fasting and Refeeding on T-cell Fate
Pilot Study to Evaluate the Effect of Fasting and Refeeding on T-Cell Fate
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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 greater than or equal to 22 and less than 30
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 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Healthy Volunteers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 24 hours
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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...
Time Frame: Visit 3, 3hrs post-meal
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Blood samples to test T-cell biology will be collected in subjects, at baseline, after a fixed caloric meal and in response to a 24-hour fast (water intake will not be restricted).
Analysis of T-cell interleukin expression and regulation and mitochondrial functioning in primary T-cells.
Analysis of mitochondrial biology in these immune-modulatory effects.
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Visit 3, 3hrs post-meal
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Evaluate whether these effects are associated with activation of the Sirt3 and its canonical mitochondrial adaptive programs.
Time Frame: Visit 3, 3hrs post-meal
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Analysis of difference in additional T-cell polarity signatures.
Analysis ofcytokine and other protein levels in serum comparing the fed versus fasted states.
Analysis of serum metabolites that may be modulating T-cell polarity.
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Visit 3, 3hrs post-meal
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael N Sack, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 160085
- 16-H-0085
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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