Protocol Details

Pilot Study to Evaluate the Effect of Fasting and Refeeding on T-Cell Fate

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	16-H-0085
Sponsoring Institute	National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 21 Years Max Age: 37 Years
Referral Letter Required	Yes
Population Exclusion(s)	Children
Keywords	NLRP3 Inflammasome; Sirtuin 3; T-Cell Polarity; Caloric Restriction; Natural History
Recruitment Keyword(s)	None
Condition(s)	Asthma; Inflammation
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Heart, Lung, and Blood Institute

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.

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Eligibility

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

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Citations:

Sack MN, Finkel T. Mitochondrial metabolism, sirtuins, and aging. Cold Spring Harb Perspect Biol. 2012 Dec 1;4(12). pii: 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. 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):106-18. doi: 10.1016/j.cell.2015.02.020.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Michael N. Sack, M.D. National Heart, Lung and Blood Institute (NHLBI) NIHBC 10 - CRC BG RM 5-3342 10 CENTER DR BETHESDA MD 20892 (301) 402-9259 ms761k@nih.gov	Rebecca D. Huffstutler, C.R.N.P. National Heart, Lung and Blood Institute (NHLBI) NIHBC 10 - CRC BG RM 5-1462 10 CENTER DR BETHESDA MD 20892 (301) 594-1281 rebecca.huffstutler@nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT02719899

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