Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 26, 2025
Date Accepted: Jul 4, 2025
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A Pilot Study Exploring the Anti-Inflammatory Effects of Time-Restricted Eating in Control and Psoriasis Subjects
ABSTRACT
Background:
Psoriasis is a chronic inflammatory disease associated with multiple comorbidities, including metabolic syndrome and cardiovascular disease. Although specific dietary interventions, such as intermittent fasting and caloric restriction, have been shown to ameliorate inflammation and promote weight loss, the effect of these interventions independent of weight loss remains unclear. Time-restricted eating (TRE), a type of intermittent fasting, limits the daily eating window to a fixed number of hours. Recent studies suggest TRE may improve immune function in individuals with metabolic syndrome and cardiovascular risk factors. A crucial advantage of TRE over other investigated dietary restriction strategies is its reported high adherence rate, making it a more feasible intervention for long-term use. Therefore, exploring the effects of TRE on metabolic and immunological parameters in psoriasis is warranted.
Objective:
This study was designed to evaluate the effects of short-term, isocaloric TRE, independent of weight loss, on immune cell function and serum metabolite profiles of volunteers with mild-to-moderate psoriasis compared to healthy control subjects.
Methods:
This pilot case-control prospective study was performed on 10 healthy male participants and 10 age-, BMI-, and sex-matched individuals with mild-to-moderate psoriasis. All psoriasis subjects had stable disease and were being treated with topical therapies without any exposure to immunomodulatory biologics. This study was conducted at the National Institutes of Health Clinical Center. Immune profiles and metabolic status of participants were assessed at baseline and after 3 days of TRE following a daily 6-hour eating window and 18-hour fast.
Results:
A total of 20 participants enrolled in this study between June 2021 and February 2023. Datasets of gene expression, surface and intracellular proteins, and metabolites are being generated from peripheral blood mononuclear cells, CD4+-enriched T-cells, and serum samples. The integrated bioinformatics analyses will be reported once the data analysis is completed.
Conclusions:
This clinical protocol was designed to characterize the effects of TRE on psoriasis, independent of weight loss, by comparing immune cell regulatory responses between control and psoriasis subjects. More specifically, we aim to map the molecular pathways activated by TRE and assess how they affect immune cell composition, activation, and metabolism. Additionally, components of the metabolic response to isocaloric TRE are being explored. Insights into how dietary interventions impact metabolism and the immune system will enhance our understanding of pathogenesis of psoriasis and may reveal new therapeutic avenues for managing this inflammatory condition. Clinical Trial: ClinicalTrials.gov NCT04728165; https://clinicaltrials.gov/study/NCT04728165
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