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PsoriasisNCT03531528

Aggressive Weight Loss Program in Chronic Plaque Psoriasis

A study testing Diet in people with Psoriasis, run by San Giuseppe Moscati Hospital at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. Besides, clinical improvement has been directly correlated with the amount of weight loss. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteItaly
Study dates
21 May 2018to 29 Oct 2018
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable chronic plaque psoriasis
  • Overweight/obese (body mass index >25 kg/m2)

Who cannot join

  • pregnancy and/or lactation
  • insulin-dependent diabetes mellitus
  • a psychiatric disorder
  • current or previous (<1 year since last chemo- or radiotherapy) neoplastic disease
  • established vascular disease
  • recent (6 months), history of diet-induced or unintentional weight loss
Show all 14Show fewer
  • moderate-to-severe heart failure
  • arrhythmia or conduction disorder
  • renal failure (creatinine >1.5 mg/dL)
  • liver failure (Child-Pugh ≥ A)
  • any type of gastrointestinal disease
  • moderate-severe hypoalbuminemia (<3.0 g/dL)
  • altered serum electrolytes
  • refusal to give written informed consent

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • A.O.R.N. "San Giuseppe Moscati"

    Avellino

Other trials in Italy

About this study

Official title: A Single-arm Trial to Evaluate the Efficacy of an Aggressive Weight Loss Program With a Ketogenic Induction Phase for the Treatment of Chronic Plaque Psoriasis

Chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. Besides, clinical improvement has been directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic diets are responsible for substantial weight loss and attenuate systemic inflammation to a higher extent than moderately hypocaloric diets. This intervention has been recently demonstrated to restore, after only 4 week, the response to biological therapy in a patient suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic induction phase in a single-arm trial that could provide the rationale for a large randomized trial.

Conditions
Psoriasis
Being tested
Diet
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DietOther

    A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet

Study groups in NCT03531528
Study groupRoleWhat they receive
ExperimentalExperimentalA 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Receives: Other: Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Psoriasis Area and Severity Index

    Change in score (on continuous scale) at the end of study

    Measured: 10 weeks

Secondary outcomes (15)

  1. Reduction in Psoriasis Area and Severity Index

    Change in score (on continuous scale) at the end of ketogenic diet-phase

    Measured: 4 weeks

  2. Reduction in Psoriasis Area and Severity Index >=75%

    Proportion of patients with change in score >=75% at the end of study

    Measured: 10 weeks

  3. Reduction in Psoriasis Area and Severity Index >=75%

    Proportion of patients with change in score >=75% at the end of ketogenic diet-phase

    Measured: 4 weeks

  4. Reduction in Psoriasis Area and Severity Index >=50%

    Proportion of patients with change in score >=50% at the end of study

    Measured: 10 weeks

  5. Reduction in Psoriasis Area and Severity Index >=50%

    Proportion of patients with change in score >=50% at the end of ketogenic diet-phase

    Measured: 4 weeks

  6. Reduction in body surface area

    Change in body surface area (on continuous scale) involved at the end of study

    Measured: 10 weeks

  7. Reduction in body surface area

    Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase

    Measured: 4 weeks

  8. Reduction in Dermatology Life Quality Index (DLQI)

    Change in DLQI (on continuous scale) at the end of study

    Measured: 10 weeks

  9. Reduction in Dermatology Life Quality Index (DLQI)

    Change in DLQI (on continuous scale) at the end of ketogenic diet-phase

    Measured: 4 weeks

  10. Reduction in itch severity

    Change in itch severity (on continuous visual analogue scale) at the end of study

    Measured: 10 weeks

  11. Reduction in itch severity

    Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase

    Measured: 4 weeks

  12. Reduction in body weight

    Change in body weight (on continuous scale) at the end of study

    Measured: 10 weeks

  13. Reduction in body weight

    Change in body weight (on continuous scale) at the end of ketogenic diet-phase

    Measured: 4 weeks

  14. Reduction in Visceral fat

    Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study

    Measured: 10 weeks

  15. Reduction in Visceral fat

    Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start21 May 2018
  3. Primary completion29 Oct 2018
  4. Study completion29 Oct 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531528
Sponsor's protocol ID
CECN/134
Status last verified
Oct 2018
First submitted
4 Apr 2018
Last updated
31 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Castaldo G, Galdo G, Rotondi Aufiero F, Cereda E. Very low-calorie ketogenic diet may allow restoring response to systemic therapy in relapsing plaque psoriasis. Obes Res Clin Pract. 2016 May-Jun;10(3):348-52. doi: 10.1016/j.orcp.2015.10.008. Epub 2015 Nov 11.

    PubMed 26559897

  • Castaldo G, Monaco L, Castaldo L, Galdo G, Cereda E. An observational study of sequential protein-sparing, very low-calorie ketogenic diet (Oloproteic diet) and hypocaloric Mediterranean-like diet for the treatment of obesity. Int J Food Sci Nutr. 2016 Sep;67(6):696-706. doi: 10.1080/09637486.2016.1186157. Epub 2016 May 18.

    PubMed 27193396

  • Castaldo G, Palmieri V, Galdo G, Castaldo L, Molettieri P, Vitale A, Monaco L. Aggressive nutritional strategy in morbid obesity in clinical practice: Safety, feasibility, and effects on metabolic and haemodynamic risk factors. Obes Res Clin Pract. 2016 Mar-Apr;10(2):169-77. doi: 10.1016/j.orcp.2015.05.001. Epub 2015 Jun 1.

    PubMed 26044613

  • Monaco L, Monaco M, Di Tommaso L, Stassano P, Castaldo L, Castaldo G. Aortomesenteric fat thickness with ultrasound predicts metabolic diseases in obese patients. Am J Med Sci. 2014 Jan;347(1):8-13. doi: 10.1097/MAJ.0b013e318288f795.

    PubMed 24366220

Questions about this trial

What is this clinical trial studying?

A study testing Diet in people with Psoriasis, run by San Giuseppe Moscati Hospital at 1 site in Italy.

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 2 inclusion and 14 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 31 Oct 2018. 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 Italy. 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?

Reduction in Psoriasis Area and Severity Index (time frame: 10 weeks). 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 NCT03531528, which also lists 4 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 31 Oct 2018.

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Clinical Trial NCT03531528 | AzTrials