Status:
COMPLETED
Anti-Inflammatory Effects of Time-Restricted Feeding
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Psoriasis
Systemic Inflammation
Eligibility:
MALE
18-80 years
Brief 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 he...
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 tra...
Eligibility Criteria
Inclusion
- 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 80 with mild to moderate active psoriasis by PASI score for inclusion in psoriasis group
- Age (plus or minus 10 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 anti-hyperglycemic 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.
Exclusion
Key Trial Info
Start Date :
June 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04728165
Start Date
June 9 2021
End Date
July 28 2023
Last Update
June 12 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892