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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Subjects will receive phototherapy and dietary counselling consistent with "The South Beach diet." |
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| 2 | Active Comparator | Subjects will receive phototherapy and dietary counselling consistent with "The Ornish Diet." |
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| 3 | Sham Comparator | Subjects will receive phototherapy alone, without dietary counselling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The South Beach Diet | Other | Subjects will receive dietary counselling aimed at reducing simple carbohydrates and increasing weight loss. Subjects also receive a copy of "The South Beach Diet." |
| Measure | Description | Time Frame |
|---|---|---|
| PASI improvement | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| which group's PASI did better | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Bagel, M.D. | Psoriasis Treatment Center of Central New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jerry Bagel | East Windsor | New Jersey | 08520 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| The Ornish Diet | Other | Subjects will receive dietary counselling aimed to reduce fat consumption and increase weight loss. Subjects also receive a copy of "The Ornish Diet" book. |
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| Control Group | Other | This group will receive phototherapy alone. They will not be counselled or give literature on a particular diet. |
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| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |