Anti-Inflammatory Effects of Time-Restricted Feeding (NCT04728165) | Clinical Trial Compass
CompletedNot Applicable
Anti-Inflammatory Effects of Time-Restricted Feeding
United States27 participantsStarted 2021-06-09
Plain-language 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....
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in the secretion of IL-17 from activated CD4+ T cells from baseline to the end of TRF
Timeframe: 3 years
Trial details
NCT IDNCT04728165
SponsorNational Heart, Lung, and Blood Institute (NHLBI)