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Completed

NCT Number: NCT04418791

Modified Intermittent Fasting in 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.

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Key information

Conditions

Psoriasis Vulgaris Behavior Fasting Feeding Behavior Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Head & Skin

Ghent, East-Flanders, 9000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Modified Intermittent Fasting followed by Regular Diet

Behavioral

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 Fasting

Behavioral

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).

Primary outcomes

  1. 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

  2. Psoriasis severity amongst subjects during and after intervention defined as Body Surface Area

    Time frame: 12 and 26 weeks

    Change in Body Surface Area

Secondary outcomes

  1. Total body fat during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in total body fat

  2. Weight during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in weight (kg)

  3. Body Mass Index during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in Body Mass Index measured as weight (kg) and height (m) (kg/m^2)

  4. Waist circumference during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in waist circumference (cm)

  5. Inflammation markers in serum during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in serological markers for inflammation [pg/ml]

  6. Inflammation markers in skin during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in cutaneous markers for inflammation [pg/ml]

  7. Metabolic markers in serum during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in serological markers for metabolism [pg/ml]

  8. Metabolic markers in skin during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in cutaneous markers for metabolism [pg/ml]

  9. Permeability markers in serum during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in serological markers for permeability [pg/ml]

  10. Permeability markers in feces during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in fecal markers for permeability [pg/ml]

  11. Visual Analogue Scale Satisfaction

    Time frame: 12 and 26 weeks

    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)

  12. Study completion by subjects

    Time frame: 12 and 26 weeks

    Number of subjects who completed the study successfully (adherence to intervention) as a percentage.

  13. Quality of life during and after intervention to baseline

    Time frame: 12 and 26 weeks

    Change in Dermatology Life Quality Index (absolute and relative)

  14. Prediction of dietary intake

    Time frame: 12 and 26 weeks

    Correlation of outcomes 1-15 in relation to dietary intake

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study 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

Acronym: MANGO

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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