Effect of Fasting and Refeeding on T-cell Fate (NCT02719899) | Clinical Trial Compass
CompletedNot Applicable
Effect of Fasting and Refeeding on T-cell Fate
United States28 participantsStarted 2016-04-18
Plain-language summary
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.
Who can participate
Age range
21 Years – 37 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 24 hours
Trial details
NCT IDNCT02719899
SponsorNational Heart, Lung, and Blood Institute (NHLBI)