Loading clinical trials...
Loading clinical trials...
Pilot Study to Explore the Anti-Inflammatory Effects of Time-Restricted Feeding
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....
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: 1. Evaluate the effect of TRF on Th17 immunological signatures. 2. Compare the role of TRF on chromatin remodeling on CD4+ T cells, monocytes and neutrophils comparing control and psoriatic subjects. 3. Evaluate the effect of TRF on glucose and insulin metabolism and overall metabolic flexibility. 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: 1. Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3). 2. Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes. 3. 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)
Age
18 - 80 years
Sex
MALE
Healthy Volunteers
No
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Start Date
June 9, 2021
Primary Completion Date
July 28, 2023
Completion Date
July 28, 2023
Last Updated
June 12, 2025
27
ACTUAL participants
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NCT07449234
NCT06200207
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07116967