Psoriasis VulgarisMANGONCT04418791
Modified Intermittent Fasting in Psoriasis
A study testing Modified Intermittent Fasting followed by Regular Diet and Regular Diet followed by Modified Intermittent Fasting in people with Psoriasis Vulgaris and Psoriasis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The complexity of psoriasis is partially affected by dietary effects, and some diets have shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of these disturbances, even inflammatory parameters such as TNF and CRP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriasis Vulgaris, Psoriasis
- What is being tested?
- Modified Intermittent Fasting followed by Regular Diet and Regular Diet followed by Modified Intermittent Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Oct 2020to 23 Feb 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild psoriasis (PASI < 10)
- At least BMI of 20
- Stable weight for last 3 months
- Topical treatment
- Availability of smartphone and willing to install app
- Willing to attend dematology clinic at Ghent University Hospital
Who cannot join
- Underweight and/or following strict diet
- Use of anti, pre and/or probiotics (last 3 months)
- Use of immunosuppressants (last 3 months)
- Smoking
- Consumption of fish oil
- Diagnosed diabetes (type ½)
Show all 10Show fewer
- Excessive physical activity
- Pregnancy or breastfeeding
- More than 14 alcohol units/week
- History of cardiac condition(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Intermittent Fasting in Psoriasis Trial: a Randomized Controlled Open Crossover Clinical Trial to Investigate the Effects of a Dietary Intervention on the Gut-skin Axis in Patients with Psoriasis
The complexity of psoriasis is partially affected by dietary effects, and some diets have shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with psoriasis have been reported to have impaired intestinal integrity and it has been suggested that gut health affects skin health, pointing towards a gut-skin axis. Understanding how dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly improve our understanding on the development of psoriasis. Modified intermittent fasting (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect on gut and skin remains underexplored.
Read the detailed description
To study the role of gut health, more specifically the intestinal barrier, in individuals with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over study. The investigators will test whether MIF can improve (i) skin lesions (clinical and molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and (iii) the timing of these improvements. As such, it can be determined whether fasting benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating between MIF and usual diet).
- Conditions
- Psoriasis Vulgaris, Psoriasis
- Being tested
- Modified Intermittent Fasting followed by Regular Diet, Regular Diet followed by Modified Intermittent Fasting
- Keywords
- Psoriasis, Fasting, Modified intermittent fasting, Leaky gut, Intestinal barrier
- Medical subject headings
- Psoriasis, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Intermittent Fasting followed by Regular DietBehavioural
Modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). After 12 weeks of fasting, a period of 12 weeks with a regular diet follows.
Regular Diet followed by Modified Intermittent FastingBehavioural
Regular diet means subject can eat as usual for 12 weeks. Next, a period of 12 weeks fasting follows: modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours).
| Study group | Role | What they receive |
|---|---|---|
| MIF-regular | Experimental | MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention. Receives: Behavioral: Modified Intermittent Fasting followed by Regular Diet |
| Regular-MIF | Experimental | Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting. Receives: Behavioral: Regular Diet followed by Modified Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
Change in Psoriasis Area Severity Index
Measured: 12 and 26 weeks
Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
Change in Body Surface Area
Measured: 12 and 26 weeks
Secondary outcomes (14)
Total body fat during and after intervention to baseline
Change in total body fat
Measured: 12 and 26 weeks
Weight during and after intervention to baseline
Change in weight (kg)
Measured: 12 and 26 weeks
Body Mass Index during and after intervention to baseline
Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)
Measured: 12 and 26 weeks
Waist circumference during and after intervention to baseline
Change in waist circumference (cm)
Measured: 12 and 26 weeks
Inflammation markers in serum during and after intervention to baseline
Change in serological markers for inflammation [pg/ml]
Measured: 12 and 26 weeks
Inflammation markers in skin during and after intervention to baseline
Change in cutaneous markers for inflammation [pg/ml]
Measured: 12 and 26 weeks
Metabolic markers in serum during and after intervention to baseline
Change in serological markers for metabolism [pg/ml]
Measured: 12 and 26 weeks
Metabolic markers in skin during and after intervention to baseline
Change in cutaneous markers for metabolism [pg/ml]
Measured: 12 and 26 weeks
Permeability markers in serum during and after intervention to baseline
Change in serological markers for permeability [pg/ml]
Measured: 12 and 26 weeks
Permeability markers in feces during and after intervention to baseline
Change in fecal markers for permeability [pg/ml]
Measured: 12 and 26 weeks
Visual Analogue Scale Satisfaction
Score of subject's rating of satisfaction and/or feasibility on intervention based on a Visual Analogue Scale going from 0 (not satisfied at all) to 10 (very satisfied)
Measured: 12 and 26 weeks
Study completion by subjects
Number of subjects who completed the study successfully (adherence to intervention) as a percentage.
Measured: 12 and 26 weeks
Quality of life during and after intervention to baseline
Change in Dermatology Life Quality Index (absolute and relative)
Measured: 12 and 26 weeks
Prediction of dietary intake
Correlation of outcomes 1-15 in relation to dietary intake
Measured: 12 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start17 Oct 2020
- Primary completion30 Jun 2021
- Study completion23 Feb 2022
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 Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418791
- Sponsor's protocol ID
- BC-6977
- Acronym
- MANGO
- Status last verified
- Sep 2024
- First submitted
- 18 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grine L, Hilhorst N, Michels N, Abbeddou S, De Henauw S, Lambert J. The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. JMIR Res Protoc. 2022 Feb 23;11(2):e26405. doi: 10.2196/26405.
PubMed 35195533
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Intermittent Fasting in Psoriasis Trial: a Randomized Controlled Open Crossover Clinical Trial to Investigate the Effects of a Dietary Intervention on the Gut-skin Axis in Patients with Psoriasis
- ClinicalTrials.gov ID
- NCT04418791
- Acronym / sponsor ID
- MANGO / BC-6977
- Conditions
- Psoriasis Vulgaris, Psoriasis
- Keywords
- Psoriasis, Fasting, Modified intermittent fasting, Leaky gut, Intestinal barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 5 Jun 2020 (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.
The complexity of psoriasis is partially affected by dietary effects, and some diets have shown to be beneficial in psoriasis. Intermittent fasting has been shown to improve many of these disturbances, even inflammatory parameters such as TNF and CRP. Individuals with psoriasis have been reported to have impaired intestinal integrity and it has been suggested that gut health affects skin health, pointing towards a gut-skin axis. Understanding how dietary lifestyles can affect epithelial lineages such as the skin and gut, will greatly improve our understanding on the development of psoriasis. Modified intermittent fasting (MIF) of 2 non-consecutive days has shown to have positive metabolic effects, yet its effect on gut and skin remains underexplored.
Detailed description
To study the role of gut health, more specifically the intestinal barrier, in individuals with psoriasis and the effects of fasting on both organs in a prospective cohort cross-over study. The investigators will test whether MIF can improve (i) skin lesions (clinical and molecular level), (ii) intestinal integrity markers such as zonulin, IFABP and sCD14, and (iii) the timing of these improvements. As such, it can be determined whether fasting benefits psoriasis and gut health. MIF will consist of a limited calorie uptake of 500 kcal for 2 days a week. The remaining days of the week are as usual. Gut and skin health will be tested at the molecular level during 12 weeks with another crossover of 12 weeks (alternating between MIF and usual diet).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIF-regular | Experimental | Behavioral: Modified Intermittent Fasting followed by Regular DietMIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention. |
| Regular-MIF | Experimental | Behavioral: Regular Diet followed by Modified Intermittent FastingRegular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild psoriasis (PASI < 10)
- At least BMI of 20
- Stable weight for last 3 months
- Topical treatment
- Availability of smartphone and willing to install app
Key exclusion criteria (10 listed)
- Underweight and/or following strict diet
- Use of anti, pre and/or probiotics (last 3 months)
- Use of immunosuppressants (last 3 months)
- Smoking
- Consumption of fish oil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Intermittent Fasting followed by Regular DietModified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). After 12 weeks of fasting, a period of 12 weeks with a regular diet follows. | Behavioural | MIF-regular |
| Regular Diet followed by Modified Intermittent FastingRegular diet means subject can eat as usual for 12 weeks. Next, a period of 12 weeks fasting follows: modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). | Behavioural | Regular-MIF |
Primary outcome
Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index
Time frame: 12 and 26 weeks
Change in Psoriasis Area Severity Index
Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area
Time frame: 12 and 26 weeks
Change in Body Surface Area
14 secondary outcomes
Total body fat during and after intervention to baseline
Time frame: 12 and 26 weeks
Weight during and after intervention to baseline
Time frame: 12 and 26 weeks
Body Mass Index during and after intervention to baseline
Time frame: 12 and 26 weeks
Waist circumference during and after intervention to baseline
Time frame: 12 and 26 weeks
Inflammation markers in serum during and after intervention to baseline
Time frame: 12 and 26 weeks
Inflammation markers in skin during and after intervention to baseline
Time frame: 12 and 26 weeks
Metabolic markers in serum during and after intervention to baseline
Time frame: 12 and 26 weeks
Metabolic markers in skin during and after intervention to baseline
Time frame: 12 and 26 weeks
Permeability markers in serum during and after intervention to baseline
Time frame: 12 and 26 weeks
Permeability markers in feces during and after intervention to baseline
Time frame: 12 and 26 weeks
Visual Analogue Scale Satisfaction
Time frame: 12 and 26 weeks
Study completion by subjects
Time frame: 12 and 26 weeks
Quality of life during and after intervention to baseline
Time frame: 12 and 26 weeks
Prediction of dietary intake
Time frame: 12 and 26 weeks
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 19 Sep 2024.
- Derived from this study: PubMed 35195533Grine L, Hilhorst N, Michels N, Abbeddou S, De Henauw S, Lambert J. The Effects of Modified Intermittent Fasting in Psoriasis (MANGO): Protocol for a Two-Arm Pilot Randomized Controlled Open Cross-over Study. JMIR Res Protoc. 2022 Feb 23;11(2):e26405. doi: 10.2196/26405.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jo Lambert, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Intermittent Fasting followed by Regular Diet and Regular Diet followed by Modified Intermittent Fasting in people with Psoriasis Vulgaris and Psoriasis, run by University Hospital, Ghent at 1 site in Belgium.
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 6 inclusion and 10 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 19 Sep 2024. 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 Belgium. 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?
Improvement in psoriasis severity amongst subjects during and after intervention defined as Psoriasis Area Severity Index (time frame: 12 and 26 weeks). The study lists 2 primary outcomes in all. 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 NCT04418791, 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 19 Sep 2024.