Anti-Inflammatory Effects of Time-Restricted Feeding
Condition: Psoriasis; Systemic Inflammation
MeSH terms: Psoriasis; Inflammation
Study type: Observational

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....
    

Detailed 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)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males between the ages of 18 and 70 with mild to moderate active psoriasis by PASI score
        for inclusion in psoriasis group Age (plus or minus 5 yrs) and BMI (plus or minus 5 kg/m2)
        matched control male subjects for inclusion in the control group. Ability to provide
        informed consent Willingness and ability to participate in study procedures
      
Keywords: Psoriasis; GLUCOSE METABOLISM; insulin metabolism; NLRP3 Inflammasome; Th17 inflammation; Natural History