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Modified Intermittent Fasting in Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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) - Excessive physical activity.
  • - Pregnancy or breastfeeding.
  • - More than 14 alcohol units/week.
- History of cardiac condition(s)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04418791
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital, Ghent
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jo Lambert, MD, PhD
Principal Investigator Affiliation University Hospital, Ghent
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris, Psoriasis
Additional Details

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).

Arms & Interventions

Arms

Experimental: MIF-regular

MIF-regular will start with modified intermittent fasting. After 12 weeks, this arm will return to regular diet with no fasting intervention.

Experimental: Regular-MIF

Regular-MIF will start with regular diet with no fasting. After 12 weeks, this arm will start with modified intermittent fasting.

Interventions

Behavioral: - Modified Intermittent Fasting followed by Regular Diet

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.

Behavioral: - Regular Diet followed by Modified Intermittent Fasting

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).

Contact a Trial Team

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International Sites

Department of Head & Skin, Ghent, East-Flanders, Belgium

Status

Address

Department of Head & Skin

Ghent, East-Flanders, 9000

Site Contact

Lynda Grine, PhD

lynda.grine@uzgent.be

003293322287

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