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The aim of our study is to compare the effectiveness of Mediterranean diet (MD) with the isocaloric Ketogenic diet (KD) on clinical and biochemical markers of inflammation in patients with obesity, psoriasis (PSO) and psoriatic arthritis (PsA).
Overall, twenty patients with body mass index (BMI) >30 kg/m2, PSO and PsA under constant systematic treatment for at least 3 months will be included in the study. They will randomly assign to two groups, starting either with MD or KD for a period of 8 weeks. After a 6-week washout interval, the two groups will cross over to the other type of diet for the same 8-week period. The primary endpoint is the change in Psoriasis Area and Severity Index (PASI) and the Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention. Secondary endpoints are changes in biochemical markers of inflammation (IL-6, IL-17, IL-22, IL-23) , in metabolic and anthropometric parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | started with MD |
|
| Group B | Other | started with KD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditteranean Diet | Other | The MD provided 20% proteins, 40% fat and 40% carbohydrates. Each participant received a brochure with a template of a daily five course (breakfast, lunch, dinner and two snacks) diet plan that provided several options for each meal and was advised to use it as a guide for the 8-week period |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index score | The primary endpoint is changes in Psoriasis Area and Severity Index (PASI), 8 weeks after each diet intervention.(score range: 0-72; higher scores indicate more severe disease). | eight weeks |
| Disease Activity Index for Psoriatic Arthritis score | The primary endpoint is changes in Disease Activity Index for Psoriatic Arthritis (DAPSA) score, 8 weeks after each diet intervention.(DAPSA<4: remission, DAPSA 4-14: low disease activity, DAPSA:14-28:moderate disease activity, DAPSA>28: high disease activity) | eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 | Secondary endpoints were biochemical markers of inflammation (IL-6) 8 weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| Interleukin-17 | Secondary endpoints were biochemical markers of inflammation (IL-17) 8 weeks after KD compared to 8-weeks MD diet intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaia Lambadiari | Athens | Attica | 12462 | Greece |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| Ketogenic Diet | Other | The KD provided approximately 34% proteins, 55% fat and 11% carbohydrates. The macronutrient targets were successfully met by replacing breakfast and two daily snacks with specifically selected food products provided by Evivios Med. Lunch and dinner were natural protein-rich dishes. Each participant received accurate teaching and a brochure that incorporated a template of a weekly diet plan from an expert dietitian. |
|
| eight weeks |
| Interleukin-22 | Secondary endpoints were biochemical markers of inflammation (IL-22) 8 weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| Interleukin-23 | Secondary endpoints were biochemical markers of inflammation (IL-23) 8 weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| Glucagon Like Peptide-1 | The investigators assessed changes in Glucagon Like Peptide-1 levels 8-weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| Oxyntomodulin | The investigators assessed changes in Oxyntomodulin levels 8-weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| Peptide YY | The investigators assessed changes in Peptide YY levels 8-weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| Ghrelin | The investigators assessed changes in Ghrelin levels 8-weeks after KD compared to 8-weeks MD diet intervention. | eight weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |