Anti-Inflammatory Effects of Time-Restricted Feeding

Psoriasis Clinical Trial

Official title: Pilot Study to Explore the Anti-Inflammatory Effects of Time-Restricted Feeding

Status Completed

Clinical Trial Summary

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....

Clinical Trial Description

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) ;

Related Conditions & MeSH terms

• Inflammation
• Psoriasis
• Systemic Inflammation

• NCT number: NCT04728165
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: June 9, 2021
• Completion date: July 28, 2023