PsoriasisNCT00537212
Study of the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
A study testing The South Beach Diet and The Ornish Diet in people with Psoriasis and Weight Loss, run by Bagel, Jerry, M.D. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Weight Loss, Diet
- What is being tested?
- The South Beach Diet and The Ornish Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2008
- 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
- Age greater than 18
- PASI score greater than 10
- BMI greater than 25
- Subjects must be willing and eligible to undergo phototherapy and
- Willing to stop all other psoriasis therapies
Who cannot join
- History of failure to respond to NB-UVB in the past.
- Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin condition that would interfere with evaluation of effect of study. intervention .
- 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.
- Use or oral or parenteral corticosteroids.
- Use of appetite suppressants or other medications know to affect appetite or weight.
- Treatment with biologic therapy in the past 3 months.
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- History of cutaneous malignancy, including any squamous cell carcinoma or melanoma or more than two basal cell carcinomas, current actinic keratoses or atypical moles.
- Evidence of photosensitivity disorder (e.g.polymorphous light eruption.
- Use of other investigational drugs, any systemic psoriasis therapy, psoralen plus ultraviolet A therapy (PUVA) within 4 weeks of study drug initiation.
- Subjects who are currently achieving good clinical control of their psoriasis on their current therapy.
- Concomitant serious illness or medical condition that may interfere with participation in the study including renal failure, hepatic failure or systemic lupus erythematosus.
- Subject currently enrolled in another investigational device or drug trial(s), or that may compromise the safety of data collection.
- Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
- Subject known to be pregnant or breastfeeding.
- Evidence of skin conditions (e.g.,eczema) other than psoriasis that would interfere with study-related evaluations of psoriasis.
- History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol.
- History of non-compliance with other therapies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis, Weight Loss, Diet
- Being tested
- The South Beach Diet, The Ornish Diet, Control Group
- Keywords
- Psoriasis, Weight loss, diet
- Medical subject headings
- Psoriasis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The South Beach DietOther
Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of "The South Beach Diet."
The Ornish DietOther
Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of "The Ornish Diet" book.
Control GroupOther
Also called Phototherapy only
This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet." Receives: Other: The South Beach Diet |
| 2 | Active comparator | Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet." Receives: Other: The Ornish Diet |
| 3 | Sham comparator | Subjects will receive phototherapy alone, without dietary counselling. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI improvement
Measured: 12 weeks
Secondary outcomes (1)
which group's PASI did better
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 posted1 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagel, Jerry, M.D.
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Jerry Bagel MD, Bagel, Jerry, M.D.
- Investigators
- Jerry Bagel, M.D., Principal investigator, Psoriasis Treatment Center of Central New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537212
- Sponsor's protocol ID
- P0-001
- Status last verified
- Aug 2019
- First submitted
- 28 Sep 2007
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Single-Blinded, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy
- ClinicalTrials.gov ID
- NCT00537212
- Acronym / sponsor ID
- P0-001
- Conditions
- Psoriasis, Weight Loss, Diet
- Keywords
- Psoriasis, Weight loss, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bagel, Jerry, M.D.
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Jun 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 1 Oct 2007 (estimated)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: The South Beach DietSubjects will receive phototherapy and dietary counselling consistent with "The South Beach diet." |
| 2 | Active comparator | Other: The Ornish DietSubjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet." |
| 3 | Sham comparator | Other: Control GroupSubjects will receive phototherapy alone, without dietary counselling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18
- PASI score greater than 10
- BMI greater than 25
- Subjects must be willing and eligible to undergo phototherapy and
- Willing to stop all other psoriasis therapies
Key exclusion criteria (17 listed)
- History of failure to respond to NB-UVB in the past.
- Presence of predominantly guttate, erythrodermic, or pustular psoriasis or any skin condition that would interfere with evaluation of effect of study. intervention .
- 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.
- Use or oral or parenteral corticosteroids.
- Use of appetite suppressants or other medications know to affect appetite or weight.
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 South Beach DietSubjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of "The South Beach Diet." | Other | 1 |
| The Ornish DietSubjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of "The Ornish Diet" book. | Other | 2 |
| Control GroupAlso: Phototherapy onlyThis group will receive phototherapy alone. They will not be counselled or give literature on a particular diet. | Other | 3 |
Primary outcome
PASI improvement
Time frame: 12 weeks
1 secondary outcome
which group's PASI did better
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 14 Aug 2019.
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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.
Jerry Bagel, M.D. principal investigator
Psoriasis Treatment Center of Central New Jersey
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 South Beach Diet and The Ornish Diet in people with Psoriasis and Weight Loss, run by Bagel, Jerry, M.D. at 1 site in United States.
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 17 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 14 Aug 2019. 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 States. 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. Some participants in this study may receive a placebo. 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?
PASI improvement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2019.