Psoriasis VulgarisMETRED-PNCT05820698
The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study
A study testing The Mediterranean style diet, The UK diet and Time-restricted eating in people with Psoriasis Vulgaris, run by King's College London at 1 site in United Kingdom.
Trial 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. Are participants' able to adhere to the allocated dietary intervention? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- The Mediterranean style diet, The UK diet and Time-restricted eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jun 2023to 2 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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
- Asthma
- Cancer in the last five years (except non-melanoma skin cancer)
- Cardiovascular disease (angina, congenital heart disease, coronary artery disease, heat attack, heart failure or stoke)
- Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, celiac disease or malabsorption diseases)
- Chronic kidney disease
- Dementia
- Eating disorders (anorexia, bulimia or binge eating disorder)
- Insulin dependent diabetes
- Liver disease
- Lupus
- Multiple sclerosis
- Rheumatoid arthritis
- Thyroid disease
- history of bariatric surgery
- history of substance abuse or alcoholism (past history of alcohol intake >60 units/men or 50 units/women), within the last 12 months
- taking medication likely to interfere with study outcomes e.g. steroids (except occasional use of inhalers), anti-inflammatories or immune-suppressive drugs
- taking blood pressure medication, but has not been on a stable dosage during the last 3 months
- not on a stable topical treatment regimen for psoriasis (if prescribed)
- currently participating in a pharmaceutical study for psoriasis treatments (topical, light, tablet, or injection therapies) or has participated in a pharmaceutical study < 3 months ago
- currently participating in another diet intervention study or has participated in a diet intervention study < 3 months ago
- unwilling to record dietary intakes using handwritten diet diaries
- not fluent in the English language
- reports to have fainted in the past during an intravenous blood test
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Metabolic Research Unit, Franklin-Wilkins Building, King's College London. 150 Stamford Street, Waterloo, London.
London, Westminser, SE1 9NH
About this study
Official title: A Feasibility Pilot Study Examining the Effect of a Mediterranean Style Diet and Time-restricted Eating on Individuals With Mild-moderate Psoriasis
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:
- Are participants' able to adhere to the allocated dietary intervention?
- What is the participants' acceptability of the allocated dietary intervention?
- What is the practicality (from a clinician's stand point) of delivering the dietary interventions?
- When adhering to the allocated intervention, are there changes in psoriasis severity?
- When adhering to the allocated intervention, are there changes in measures of body composition?
- When adhering to the allocated intervention, are there changes in fasting blood measures?
Read more
Participants will attend an initial clinic visit for a fasting blood sample, psoriasis examination, body composition measurements, and will complete short multiple-choice questionnaires on the severity of their psoriasis. A Research Nutritionist will deliver the diet interventions as diet consultation sessions. These sessions are reoccurring throughout the study as virtual consultation booster sessions, which are supplemented with wellbeing check-in calls. Participants will complete short questionnaires on the severity of their psoriasis and will record their dietary intake for 4 days, before the start of the study, and on week 1, week 6, and week 12 of the study. The allocated diet should be adhered to for 12 weeks until the end of the study, where participants will return and attend a final clinic visit to repeat the measures obtained during the initial clinic visit.
Researchers will compare the feasibility of implementing a Mediterranean style diet and a Mediterranean style diet with time-restricted eating, with a UK diet with time-restricted eating.
Read the detailed description
The METRED-P study is a 12-week dietary intervention in individuals with mild-moderate psoriasis. Participants will be randomly allocated to one of three groups: a Mediterranean style diet only, a Mediterranean style diet with time-restricted eating or a UK diet with time-restricted eating.
The funding organisation (the Psoriasis Association) will support with recruitment by advertising the study on their website, on their various social media platforms, and in their monthly newsletter. Flyers will be displayed in Participant Identification Centers as well as on campus at King's College London. Social media will be used to promote the study and the study will also be advertised in the biweekly recruitment newsletter that is circulated to the staff and student population at King's College London.
Individuals responding to the study advertisements will be emailed an information sheet to evaluate if the METRED-P study is suitable for them. An eligibility video call will be arranged with the Research Nutritionist, to verify the volunteer meets the inclusion criteria, explain the information sheet and the informed consent process, and address any questions. Eligible respondents will be invited to an online video screening consultation on Microsoft Teams with the Research Nutritionist and Consultant Dermatologist to confirm their eligibility. The eligibility call and screening consultation will not be recorded and will be conducted confidentially, in a private office. Volunteers who meet the inclusion criteria will be invited to attend a screening clinic visit in the Metabolic Research Unit, 4th floor (Corridor A) at King's College London, 150 Stamford Street, SE1 9NH. The volunteer will be asked to complete the consent form and provide a fasted blood sample for a total of 13mL of blood (approximately 3.5 teaspoons) . A brief physical examination will be undertaken inclusive of weight, height, waist and hip circumference, body composition (% body fat) and clinic blood pressure. Participants will enrol in the the METRED-P study according to the inclusion and exclusion criteria and upon completing a 4-day diet diary assessment of habitual nutrient intake.
Eligible participants who passed the screening stages, will complete a hand-written 4-day diet diary and submit it by email to the Research Nutritionist prior to the initial clinic visit. Participants will arrive to the clinic at approximately 08:00AM, after a 12-hour overnight fast. A fasting blood sample will be taken intravenously for a total of 18mL of blood (approximately 4.5 teaspoons). Psoriasis severity will be assessed by the Consultant Dermatologist. Body composition and clinic blood pressure measures will be taken by the Research Nutritionist. Based on the pre-clinic 4-day diet diary, participants will receive personalised dietary guidance on their allocated dietary intervention, which should be adhered to for the duration of the study. On week 4 and week 8 of the study, virtual dietary consultation booster sessions will be arranged with the Research Nutritionist to reinforce the dietary advice and to maximise adherence with the allocated dietary interventions. Participants will also complete short multiple-choice questionnaires on the severity of their psoriasis. Wellbeing check-in calls are scheduled on week 2, week 6 and week 10 with the Research Nutritionist to ensure participant well-being and address any compliance issues. Participants will return for a clinic visit at the end of the study, to repeat the measures obtained at the initial visit and complete an exit questionnaire.
- Conditions
- Psoriasis Vulgaris
- Being tested
- The Mediterranean style diet, The UK diet, Time-restricted eating
- Keywords
- Diet, Inflammation, Mediterranean diet, Time-restricted eating, Nutrition
- Medical subject headings
- Inflammation, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Mediterranean style dietOther
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 UK dietOther
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.
Time-restricted eatingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: The UK diet; Other: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
The acceptability of the allocated dietary intervention, as assessed by participant records.
Expressed as rates of participant recruitment, attrition, and compliance.
Measured: 12 weeks
The practicality of delivering the dietary interventions, as assessed with a exit questionnaire.
Expressed as the percentages of participant responses.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start8 Jun 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 King's College LondonThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Psoriasis Association
- Responsible party
- Sponsor
- Investigators
- Wendy L Hall, PhD, Principal investigator, Reader in Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820698
- Sponsor's protocol ID
- HR/DP-22/23-34784
- Acronym
- METRED-P
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10468786Pascoe 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.
PubMed 25549367Finlay 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.
PubMed 8033378Topp 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.
PubMed 25831962Chularojanamontri 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.
PubMed 23807685
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Pilot Study Examining the Effect of a Mediterranean Style Diet and Time-restricted Eating on Individuals With Mild-moderate Psoriasis
- ClinicalTrials.gov ID
- NCT05820698
- Acronym / sponsor ID
- METRED-P / HR/DP-22/23-34784
- Conditions
- Psoriasis Vulgaris
- Keywords
- Diet, Inflammation, Mediterranean diet, Time-restricted eating, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Psoriasis Association
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 20 Apr 2023 (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 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:
- Are participants' able to adhere to the allocated dietary intervention?
- What is the participants' acceptability of the allocated dietary intervention?
- What is the practicality (from a clinician's stand point) of delivering the dietary interventions?
- When adhering to the allocated intervention, are there changes in psoriasis severity?
- When adhering to the allocated intervention, are there changes in measures of body composition?
- When adhering to the allocated intervention, are there changes in fasting blood measures?
Participants will attend an initial clinic visit for a fasting blood sample, psoriasis examination, body composition measurements, and will complete short multiple-choice questionnaires on the severity of their psoriasis. A Research Nutritionist will deliver the diet interventions as diet consultation sessions. These sessions are reoccurring throughout the study as virtual consultation booster sessions, which are supplemented with wellbeing check-in calls. Participants will complete short questionnaires on the severity of their psoriasis and will record their dietary intake for 4 days, before the start of the study, and on week 1, week 6, and week 12 of the study. The allocated diet should be adhered to for 12 weeks until the end of the study, where participants will return and attend a final clinic visit to repeat the measures obtained during the initial clinic visit.
Researchers will compare the feasibility of implementing a Mediterranean style diet and a Mediterranean style diet with time-restricted eating, with a UK diet with time-restricted eating.
Detailed description
The METRED-P study is a 12-week dietary intervention in individuals with mild-moderate psoriasis. Participants will be randomly allocated to one of three groups: a Mediterranean style diet only, a Mediterranean style diet with time-restricted eating or a UK diet with time-restricted eating.
The funding organisation (the Psoriasis Association) will support with recruitment by advertising the study on their website, on their various social media platforms, and in their monthly newsletter. Flyers will be displayed in Participant Identification Centers as well as on campus at King's College London. Social media will be used to promote the study and the study will also be advertised in the biweekly recruitment newsletter that is circulated to the staff and student population at King's College London.
Individuals responding to the study advertisements will be emailed an information sheet to evaluate if the METRED-P study is suitable for them. An eligibility video call will be arranged with the Research Nutritionist, to verify the volunteer meets the inclusion criteria, explain the information sheet and the informed consent process, and address any questions. Eligible respondents will be invited to an online video screening consultation on Microsoft Teams with the Research Nutritionist and Consultant Dermatologist to confirm their eligibility. The eligibility call and screening consultation will not be recorded and will be conducted confidentially, in a private office. Volunteers who meet the inclusion criteria will be invited to attend a screening clinic visit in the Metabolic Research Unit, 4th floor (Corridor A) at King's College London, 150 Stamford Street, SE1 9NH. The volunteer will be asked to complete the consent form and provide a fasted blood sample for a total of 13mL of blood (approximately 3.5 teaspoons) . A brief physical examination will be undertaken inclusive of weight, height, waist and hip circumference, body composition (% body fat) and clinic blood pressure. Participants will enrol in the the METRED-P study according to the inclusion and exclusion criteria and upon completing a 4-day diet diary assessment of habitual nutrient intake.
Eligible participants who passed the screening stages, will complete a hand-written 4-day diet diary and submit it by email to the Research Nutritionist prior to the initial clinic visit. Participants will arrive to the clinic at approximately 08:00AM, after a 12-hour overnight fast. A fasting blood sample will be taken intravenously for a total of 18mL of blood (approximately 4.5 teaspoons). Psoriasis severity will be assessed by the Consultant Dermatologist. Body composition and clinic blood pressure measures will be taken by the Research Nutritionist. Based on the pre-clinic 4-day diet diary, participants will receive personalised dietary guidance on their allocated dietary intervention, which should be adhered to for the duration of the study. On week 4 and week 8 of the study, virtual dietary consultation booster sessions will be arranged with the Research Nutritionist to reinforce the dietary advice and to maximise adherence with the allocated dietary interventions. Participants will also complete short multiple-choice questionnaires on the severity of their psoriasis. Wellbeing check-in calls are scheduled on week 2, week 6 and week 10 with the Research Nutritionist to ensure participant well-being and address any compliance issues. Participants will return for a clinic visit at the end of the study, to repeat the measures obtained at the initial visit and complete an exit questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Mediterranean style diet | Experimental | Other: The Mediterranean style dietParticipants in the Mediterranean style diet arm (n = 12) will receive dietary advice to follow a Mediterranean style diet by the Research Nutritionist. |
| The Mediterranean style diet with time-restricted eating | Experimental | Other: The Mediterranean style diet, Other: Time-restricted eatingParticipants 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. |
| The UK diet with time-restricted eating | Active comparator | Other: The UK diet, Other: Time-restricted eatingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (38 listed)
- 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
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 |
|---|---|---|
| The Mediterranean style dietParticipants 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. | Other | The Mediterranean style diet, The Mediterranean style diet with time-restricted eating |
| The UK dietParticipants 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. | Other | The UK diet with time-restricted eating |
| Time-restricted eatingParticipants 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 | Other | The Mediterranean style diet with time-restricted eating, The UK diet with time-restricted eating |
Primary outcome
Average adherence to the diet intervention after 1 week, as assessed by the MEditerranean Diet Adherence Screener (MEDAS).
Time frame: 1 week
0-5 points = low adherence, 6-9 points = moderate adherence and 10-14 points = high adherence.
Average adherence to the diet intervention after 6 weeks, as assessed by the MEditerranean Diet Adherence Screener (MEDAS).
Time frame: 6 weeks
0-5 points = low adherence, 6-9 points = moderate adherence and 10-14 points = high adherence.
Average adherence to the diet intervention after 12 weeks, as assessed by the MEditerranean Diet Adherence Screener (MEDAS).
Time frame: 12 weeks
0-5 points = low adherence, 6-9 points = moderate adherence and 10-14 points = high adherence.
2 secondary outcomes
The acceptability of the allocated dietary intervention, as assessed by participant records.
Time frame: 12 weeks
The practicality of delivering the dietary interventions, as assessed with a exit questionnaire.
Time frame: 12 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 4 May 2025.
- Background: PubMed 10468786Ashcroft 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.
- Background: PubMed 25549367Pascoe 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.
- Background: PubMed 8033378Finlay 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.
- Background: PubMed 25831962Topp 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.
- Background: PubMed 23807685Chularojanamontri 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.
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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.
Wendy L Hall, PhD principal investigator
Reader in Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Mediterranean style diet, The UK diet and Time-restricted eating in people with Psoriasis Vulgaris, run by King's College London at 1 site in United Kingdom.
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 38 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 4 May 2025. 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 Kingdom. 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?
Average adherence to the diet intervention after 1 week, as assessed by the MEditerranean Diet Adherence Screener (MEDAS). (time frame: 1 week). The study lists 3 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 NCT05820698, which also lists 5 linked publications.
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 4 May 2025.