PsoriasisNCT04728165
Anti-Inflammatory Effects of Time-Restricted Feeding
An observational study of Psoriasis and Systemic Inflammation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Psoriasis, Systemic Inflammation
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 28 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study to Explore the Anti-Inflammatory Effects of Time-Restricted Feeding
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.
Read more
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....
Read the 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:
- Evaluate the effect of TRF on Th17 immunological signatures.
- Compare the role of TRF on chromatin remodeling on CD4+ T cells, monocytes and neutrophils comparing control and psoriatic subjects.
- 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:
- Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3).
- Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes.
- 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)
- Conditions
- Psoriasis, Systemic Inflammation
- Keywords
- Psoriasis, GLUCOSE METABOLISM, insulin metabolism, NLRP3 Inflammasome, Th17 inflammation, Natural History
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the secretion of IL-17 from activated CD4+ T cells from baseline to the end of TRF
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.
Measured: 3 years
Secondary outcomes (3)
Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3)
Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3)
Measured: 5 years
Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes
Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes.
Measured: 5 years
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 substra...
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)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start9 Jun 2021
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rachael J Klein, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728165
- Sponsor's protocol ID
- 10000149
- Other IDs
- 000149-H
- Status last verified
- 29 Jul 2026
- First submitted
- 27 Jan 2021
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romero Arocha S, Han K, Huffstutler RD, Thota GP, Macheret NA, Courville AB, Brychta RJ, Chen KY, Chung ST, Coates LC, Clarke AJ, Sack MN. Effects of Acute Time-Restricted Eating on Inflammation in Individuals With Psoriasis: Protocol for a Case-Control, Prospective Study. JMIR Res Protoc. 2025 Aug 15;14:e74999. doi: 10.2196/74999.
PubMed 40815832
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Explore the Anti-Inflammatory Effects of Time-Restricted Feeding
- ClinicalTrials.gov ID
- NCT04728165
- Acronym / sponsor ID
- 10000149
- Conditions
- Psoriasis, Systemic Inflammation
- Keywords
- Psoriasis, GLUCOSE METABOLISM, insulin metabolism, NLRP3 Inflammasome, Th17 inflammation, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the effect of TRF on Th17 immunological signatures.
- Compare the role of TRF on chromatin remodeling on CD4+ T cells, monocytes and neutrophils comparing control and psoriatic subjects.
- 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:
- Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3).
- Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes.
- 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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in the secretion of IL-17 from activated CD4+ T cells from baseline to the end of TRF
Time frame: 3 years
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.
3 secondary outcomes
Evaluate the effect of TRF on chromatin signatures of gene activation (ATACseq) and gene silencing (H3K9me3)
Time frame: 5 years
Explore the effect of TRF on low-density granulocytes, neutrophils and monocytes
Time frame: 5 years
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 substra...
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 40815832Romero Arocha S, Han K, Huffstutler RD, Thota GP, Macheret NA, Courville AB, Brychta RJ, Chen KY, Chung ST, Coates LC, Clarke AJ, Sack MN. Effects of Acute Time-Restricted Eating on Inflammation in Individuals With Psoriasis: Protocol for a Case-Control, Prospective Study. JMIR Res Protoc. 2025 Aug 15;14:e74999. doi: 10.2196/74999.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael J Klein, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Systemic Inflammation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the secretion of IL-17 from activated CD4+ T cells from baseline to the end of TRF (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.