The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study

NCT05820698 | Completed DMC

• 1 other identifier: HR/DP-22/23-34784
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The METRED-P study will test the feasibility of implementing a Mediterranean style diet and/or time-restricted eating as dietary patterns in individuals with psoriasis. This study will address the following research questions:

1. 1.Are participants' able to adhere to the allocated dietary intervention?
2. 2.What is the participants' acceptability of the allocated dietary intervention?
3. 3.What is the practicality (from a clinician's stand point) of delivering the dietary interventions?
4. 4.When adhering to the allocated intervention, are there changes in psoriasis severity?
5. 5.When adhering to the allocated intervention, are there changes in measures of body composition?
6. 6.When adhering to the allocated intervention, are there changes in fasting blood measures?

Conditions

Psoriasis Vulgaris

Keywords

Diet; Inflammation; Mediterranean diet; Time-restricted eating; Nutrition

Outcome Measures

Primary Outcomes (3)

• Average adherence to the diet intervention after 1 week, as assessed by the MEditerranean Diet Adherence Screener (MEDAS).

  0-5 points = low adherence, 6-9 points = moderate adherence and 10-14 points = high adherence.

  1 week

• Average adherence to the diet intervention after 6 weeks, as assessed by the MEditerranean Diet Adherence Screener (MEDAS).

  0-5 points = low adherence, 6-9 points = moderate adherence and 10-14 points = high adherence.

  6 weeks

• Average adherence to the diet intervention after 12 weeks, as assessed by the MEditerranean Diet Adherence Screener (MEDAS).

  0-5 points = low adherence, 6-9 points = moderate adherence and 10-14 points = high adherence.

  12 weeks

Secondary Outcomes (2)

• The acceptability of the allocated dietary intervention, as assessed by participant records.

  12 weeks

• The practicality of delivering the dietary interventions, as assessed with a exit questionnaire.

  12 weeks

Other Outcomes (34)

• Change between baseline and week 12 psoriasis severity, as assessed by the Psoriasis Area Severity Index (PASI).

  12 weeks

• Change in baseline self-reported psoriasis severity at 4 weeks, as assessed by the self-assessed Simplified Psoriasis Index (sa-SPI).

  4 weeks

• Change in baseline self-reported psoriasis severity at 8 weeks, as assessed by the self-assessed Simplified Psoriasis Index (sa-SPI).

  8 weeks

Study Arms (3)

The Mediterranean style diet

EXPERIMENTAL

Participants in the Mediterranean style diet arm (n = 12) will receive dietary advice to follow a Mediterranean style diet by the Research Nutritionist.

Other: The Mediterranean style diet

The Mediterranean style diet with time-restricted eating

EXPERIMENTAL

Participants in the Mediterranean style diet with time-restricted eating arm (n = 12) will receive dietary advice to follow a Mediterranean style diet combined with time-restricted eating by the Research Nutritionist.

Other: The Mediterranean style diet; Other: Time-restricted eating

The UK diet with time-restricted eating

ACTIVE COMPARATOR

Participants in the UK diet with time-restricted eating arm (n = 12) will receive dietary advice to follow a UK diet combined with time-restricted eating by the Research Nutritionist.

Other: The UK diet; Other: Time-restricted eating

Interventions

The Mediterranean style diet OTHER

Participants in the Mediterranean style diet group will be provided with recommendations to include a minimum of 5 servings of fruits and vegetables (combined) per day, 2 servings of whole grains per meal per day, at least two servings of extra virgin olive oil per day, a maximum two servings of dairy products per day (excluding milk in coffee/tea), a minimum of 3 servings of fish per week (of which two should be oily fish), less than 2 servings of red meat or processed meat per week. Confectionary and sugar sweetened beverages should be limited to less than 2 servings per week. Participants randomised to the Mediterranean style intervention will be provided with support documents including a dietary guideline booklet, recipes, meal plans, shopping and product swap lists, as well as eating-out and budget-eating advice sheets. Food deliveries containing key food items of the diet intervention will be scheduled for week 1, week 4, and week 8 of the study.

The Mediterranean style diet; The Mediterranean style diet with time-restricted eating

The UK diet OTHER

Participants in the UK diet with time-restricted eating group will be provided with recommendations of a nutritionally balanced diet, corresponding to the average intakes of the UK population. Participants will be advised to consume no more than 4 portions of fruits and vegetables combined per day, to have at least two servings of dairy per day, to limit the consumption of white fish to less than 1 serving per week, with ≤1 serving of oily fish per month. Nuts and seeds consumption should also be limited to ≤1 serving per week and at least 3 servings of white and red meat should be consumed per week. Participants randomised to the UK diet will be provided with support documents including a dietary guideline booklet, recipes, and meal plans. A £30 reimbursement will be provided to participants for their grocery shopping on week 1, week 4, and week 8 of the study.

The UK diet with time-restricted eating

Time-restricted eating OTHER

Participants randomised to the time-restricted eating interventions will be advised to limit food intake to a 10-hour eating window and to abstain from food intake for a 14-hour fasting window. Hydration is to be maintained during the fasting window with water and/or plain teas/coffees

The Mediterranean style diet with time-restricted eating; The UK diet with time-restricted eating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (aged 18 years or older)
• a medical diagnosis of plaque psoriasis
• a baseline Psoriasis Area Severity Index score between 5-10 (evaluated during screening)
• a Body Mass Index between 20-40
• not on tablet or injection therapies for psoriasis, OR if on tablet or injection therapies, is 6 months stable on the same dose of tablet or injection therapies

You may not qualify if:

• is taking Cyclosporine or Stelara in the past 3 months
• is receiving or has received photo (light) therapies for psoriasis in the past 3 months
• is a shift worker or is involved in shift work
• is planning on international travel during the study period
• is not weight stable or has attempted to lose weight during the past 6 months
• diagnosis of a gluten, nut, peanut, fish, or shellfish allergy
• diagnosis of a gluten or dairy intolerance
• is following a restrictive diet/restricting food groups i.e vegan, vegetarian, gluten-free , or a Mediterranean style diet
• is following any intermittent fasting regimes inclusive of 5:2, alternate day fasting or modified alternate day fasting, time-restricted eating over the past 6 months
• reports a habitual eating window \< 12 h per day
• reports a baseline healthy diet (e.g. \> 5 servings of fruits and vegetables per day, 1 serving of nuts per day , 2 servings of whole grains per day, 2 servings of fish per week, \> 1 servings of nuts per day and rarely eats sweet snacks, cakes, fried foods and red meat).
• taking fish oil or other dietary supplements (except daily multivitamins providing no more than 200% of UK dietary recommended values)
• currently pregnant, currently breastfeeding or planning to become pregnant in the next 4 months
• is or has been diagnosed in the past with any of the following:
• Anaemia

Sponsors & Collaborators

• King's College London: lead
• Psoriasis Association: collaborator

Study Sites (1)

Metabolic Research Unit, Franklin-Wilkins Building, King's College London. 150 Stamford Street, Waterloo, London.

London, Westminser, SE1 9NH, United Kingdom

Location

Related Publications (5)

• Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol. 1999 Aug;141(2):185-91. doi: 10.1046/j.1365-2133.1999.02963.x.

  PMID: 10468786 BACKGROUND

• Pascoe VL, Enamandram M, Corey KC, Cheng CE, Javorsky EJ, Sung SM, Donahue KR, Kimball AB. Using the Physician Global Assessment in a clinical setting to measure and track patient outcomes. JAMA Dermatol. 2015 Apr;151(4):375-81. doi: 10.1001/jamadermatol.2014.3513.

  PMID: 25549367 BACKGROUND

• Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.

  PMID: 8033378 BACKGROUND

• Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

  PMID: 25831962 BACKGROUND

• Chularojanamontri L, Griffiths CE, Chalmers RJ. The Simplified Psoriasis Index (SPI): a practical tool for assessing psoriasis. J Invest Dermatol. 2013 Aug;133(8):1956-62. doi: 10.1038/jid.2013.138. Epub 2013 Mar 20.

  PMID: 23807685 BACKGROUND

MeSH Terms

Conditions

Inflammation; Intermittent Fasting

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Wendy L Hall, PhD

  Reader in Nutritional Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the nature of dietary interventions, blinding will not always be possible, and this study will be conducted in an unblinded manner. Only the Consultant Dermatologist (Outcome Assessor) undertaking the psoriasis severity examinations will be blinded to the allocated diet interventions of the participants. All statistical data analysis will be carried out blinded using data codes to ensure that the intervention allocation is concealed from the researcher carrying out the statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 20, 2023
• Study Start: June 8, 2023
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: May 4, 2025

Record last verified: 2024-03

Locations

GB (1)