Anti-Inflammatory Effects of Time-Restricted Feeding

Study Purpose

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 70 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 70 Years
Gender Male
More Inclusion & Exclusion Criteria

  • -

    INCLUSION CRITERIA:

    Individuals must meet the inclusion criteria listed below in order to be eligible to participate in the study.
  • - 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/m^2) matched control male subjects for inclusion in the control group.
  • - Ability to provide informed consent.
  • - Willingness and ability to participate in study procedures.

EXCLUSION CRITERIA:

  • - Severe psoriasis by PASI (Psoriasis Area and Severity Index) score > 12.
  • - Treatment with systemic biologic immune modifying agents within the last 2 months.
  • - Currently on treatment for allergies or other inflammatory diseases.
  • - Has taken Vitamin B or tryptophan supplementation within 2 weeks of participation.
  • - Unwillingness/inability to provide informed consent.
  • - Individuals with known history of type 1 and 2 diabetes mellitus or other metabolic conditions that would interfere with study parameters including chronic kidney disease, chronic liver disease, history of hypoglycemia.
  • - On treatment with medication that would interfere with study parameters including antihyperglycemic medications, systemic steroids, adrenergic-stimulating agents, other medications known to affect sleep, circadian rhythms or metabolism.
  • - Caffeine in excess of three 8 oz cups per day.
  • - Factors that affect circadian rhythm including individuals who perform overnight shift work, irregular sleep and/ or eating schedules, regularly fast for more than 15 hours/ day.
  • - Regular use of tobacco product within last 3 months.
  • - Consuming more than 3 servings of alcohol/ day.
  • - Engaged in competitive sports training.
  • - Moderate to severe claustrophobia.
  • - Unstable weight with more than 5% body weight change in last 3 months.
  • - Food allergies or intolerances or dietary patterns that would prohibit consumption of the metabolic diet or mixed meal test.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04728165
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael N Sack, M.D.
Principal Investigator Affiliation National Heart, Lung, and Blood Institute (NHLBI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Systemic Inflammation
Study Website: View Trial Website
Additional Details

Study Rationale. We have previously shown that fasting, and the caloric restriction mimetic nicotinamide riboside (NR) confer anti-inflammatory effects on a broad array of circulating innate and adaptive immune cells. Three major effects include fasting-mediated blunting of the NLRP3 inflammasome and of CD4+Th17 responsiveness, and of NR-induced downregulation of monocytic type 1 interferon signaling. In parallel, dietary interventions including intermittent fasting (IF- alternate day eating) and time-restricted feeding (TRF- for e.g. eating during the first 6 hours after waking each day) reduce inflammatory and cardiometabolic risk factors. Animal studies suggest that pharmacologic mimics of dietary restriction are inferior to dietary manipulations themselves. This discrepancy is postulated to be due to wide array of biological responses evoked by the 'low levels of stress' (hormesis) evoked by IF or TRF compared to the targeting of distinct biological pathways. Hence to advance our understanding on the role of these dietary interventions on immune modulation in health and disease, a pilot study is being planned to test the effect of TRF in subjects with mild to moderate psoriasis compared to a matched healthy control population. For this pilot study we elected to employ TRF over IF, as this will enable repetitive hormesis periods in a relative short time span to compare TRF immunological signatures to conventional dietary intervals. This initial study will be domiciled in the Clinical Center Metabolic Unit in collaboration with NIDDK Investigators, to ensure complete adherence to the TRF in this initial proof of concept study. Psoriasis has been selected as the disease comparator to the control group in this initial study, as this is a chronic inflammatory skin disease that effects cardiometabolic risk and is linked to both the NLRP3 inflammasome and Th17 inflammation.

Arms & Interventions

Arms

: control group

Age (+/-5 yrs) and BMI (+/- 5 kg/m2) matched control male subjects for inclusion in the control group

: psoriasis group

Males between the ages of 18 and 70 with mild to moderate active psoriasis by PASI score for inclusion in psoriasis group

Interventions

Contact a Trial Team

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Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY8664111010

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