Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy

August 12, 2019 updated by: Jerry Bagel MD, Bagel, Jerry, M.D.

A Single-Center, Prospective, Single-Blinded, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy

The association between psoriasis and obesity has been questioned by physicians for many years. Studies have shown that the risk of having psoriasis is increased in people with a high body mass index, which is a measurement of obesity. There have been case reports of remission of psoriasis after gastric bypass surgery. Furthermore, other studies have shown that certain inflammatory diseases (such as rheumatoid arthritis) can be improved by dietary changes. The purpose of this study is to assess whether a low carbohydrate or low fat diet can be helpful in the treatment of psoriasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study involves the use of diet as a therapeutic agent in subjects with obesity and psoriasis who are eligible for and willing to undergo phototherapy. Subjects undergoing phototherapy alone will be compared to subjects randomized to receive phototherapy and dietary modification with the goal of weight loss. The primary objective is to determine the success rate of weight loss programs in the setting of psoriasis. Secondary objectives include evaluating the effect of weight loss on efficacy of narrow band ultraviolet B phototherapy, and assessing the efficacy of lower carbohydrate and low fat diets in psoriatic patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Jerry Bagel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age greater than 18
  2. PASI score greater than 10
  3. BMI greater than 25
  4. Subjects must be willing and eligible to undergo phototherapy and
  5. Willing to stop all other psoriasis therapies

Exclusion Criteria:

  1. History of failure to respond to NB-UVB in the past.
  2. Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin condition that would interfere with evaluation of effect of study. intervention .
  3. Treatment with systemic antibiotics, topical steroids (except to groin and face), topical Vitamin A or D analogs, or ultraviolet B therapy within 2 weeks of study initiation.
  4. Use or oral or parenteral corticosteroids.
  5. Use of appetite suppressants or other medications know to affect appetite or weight.
  6. Treatment with biologic therapy in the past 3 months.
  7. History of cutaneous malignancy, including any squamous cell carcinoma or melanoma or more than two basal cell carcinomas, current actinic keratoses or atypical moles.
  8. Evidence of photosensitivity disorder (e.g.polymorphous light eruption.
  9. Use of other investigational drugs, any systemic psoriasis therapy, psoralen plus ultraviolet A therapy (PUVA) within 4 weeks of study drug initiation.
  10. Subjects who are currently achieving good clinical control of their psoriasis on their current therapy.
  11. Concomitant serious illness or medical condition that may interfere with participation in the study including renal failure, hepatic failure or systemic lupus erythematosus.
  12. Subject currently enrolled in another investigational device or drug trial(s), or that may compromise the safety of data collection.
  13. Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
  14. Subject known to be pregnant or breastfeeding.
  15. Evidence of skin conditions (e.g.,eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis.
  16. History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol.
  17. History of non-compliance with other therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet."
Other: The South Beach Diet
Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of "The South Beach Diet."
Active Comparator: 2
Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet."
Other: The Ornish Diet
Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of "The Ornish Diet" book.
Sham Comparator: 3
Subjects will receive phototherapy alone, without dietary counselling.
Other: Control Group
This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.
Other Names:
  • Phototherapy only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
PASI improvement
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
which group's PASI did better
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bagel, Jerry, M.D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Food and Drug Administration (FDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jerry Bagel, M.D., Psoriasis Treatment Center of Central New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P0-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis

Clinical Trials on The South Beach Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings