National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
NCT Number: NCT04728165
Background:
Time-restricted feeding (TRF) means that a person eats only during certain hours of the day. In other studies, researchers have found that fasting can improve immune system function in healthy people. They want to see if TRF has the same effect on people with psoriasis.
Objective:
To test whether TRF can change metabolism and decrease some markers of inflammation in the blood of people with mild to moderate psoriasis.
Eligibility:
Males ages 18 to 80 with mild to moderate active psoriasis, and healthy volunteers
Design:
Participants will be screened with a medical history and medicine review. They will have a physical exam and blood tests. Their skin will be examined. They will have a nutritional evaluation. Their resting energy expenditure will be measured. For this, a clear plastic ventilation hood will be placed over the head for a short time.
Participants will stay at the NIH Clinical Center for 4 1/2 days. They can watch TV, do work, do schoolwork, and other quiet activities.
A small sensor will be placed under participants skin to measure blood glucose.
For part of the study, participants will be housed in a small room called a metabolic chamber. They will wear a heart monitor.
Participants will walk on a treadmill for 30 minutes each day at a comfortable speed.
For 3 days, participants will eat all their daily calories between 8 am and 2 pm. They will fast for the other 18 hours of the day. They can drink water.
Participants will complete mixed meal tests. They will drink a liquid meal for breakfast. Then they will give blood samples via intravenous (IV) catheter.
Participation will last for 5 days....
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Notify Me18 year–80 year
Male
Observational
Bethesda, Maryland, 20892, United States
Study Description:
Fasting and caloric restriction interventions have anti-inflammatory effects, although the underling regulatory controls are poorly characterized. This pilot study will explore transcriptional profiles in various leukocyte populations comparing the effect of time restricted feeding (TRF - 6-Hr feeding/18-Hr fast) to a more conventional dietary regimen (12-Hr feeding/12Hr fast). These regulatory effects will be evaluated in an inflammatory disease (psoriasis) in response to TRF and by comparing the relative response comparing the psoriasis population to a matched TRF control group.
Objectives:
psoriatic subjects.
Endpoints:
The primary outcome will be the change in the secretion of IL-17 from activated CD4+ T cells from baseline to the end of TRF as a measure of biological reprograming in the psoriasis group and to assess the change in IL-17 release comparing the effects of TRF in the control versus psoriasis groups.
Secondary outcomes are:
and feeding metabolic flexibility as defined by the change in sleeping respiratory exchange ratio from the daytime. (24-hr
substrate oxidation as defined by the averaged RER)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Individuals must meet the inclusion criteria listed below in order to be eligible to participate in the study.
Exclusion criteria
Time frame: 3 years
The primary outcome will be the change in the secretion of IL-17 from activated CD4+ T cells from baseline to the end of TRF as a measure of biological reprograming in the psoriasis group and to assess the change in IL-17 release comparing the effects of TRF in the control versus psoriasis groups.
Time frame: 5 years
Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3)
Time frame: 5 years
Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes.
Time frame: 4 years
Evaluate whether TRF improves 24-hour glucose levels, glycemic excursions during a meal test and modulate sleeping and feeding metabolic flexibility as defined by the change in sleeping respiratory exchange ratio from the daytime. (24-hr substrate oxidation as defined by the averaged RER)
National Heart, Lung, and Blood Institute (NHLBI)
Nih
Pilot Study to Explore the Anti-Inflammatory Effects of Time-Restricted Feeding
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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