The DIET Trial - Dietetic Intervention in Psoriatic Arthritis

NCT ID: NCT03142503

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-21
• Study Completion Date: 2015-06-22

Brief Summary

Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and inflammation are also contributing mechanisms on Ps and PsA. However, little is known about the influence of diet and micronutrients on the main outcomes of these diseases. The aim of the investigators is to evaluate the effectiveness of an intervention diet program on disease activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic Arthritis.

Conditions

Arthritis, Psoriatic; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Soybean supplementation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Supplementation of 1g soybean oil, 3 times a day.

Diet + placebo

Soybean supplementation and diet intervention

Group Type: ACTIVE_COMPARATOR

Diet + placebo

Intervention Type: DIETARY_SUPPLEMENT

Supplementation of 1g of soybean oil, 3 times a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.

Diet + Supplementation

Omega 3 and diet intervention

Group Type: EXPERIMENTAL

Diet + supplementation

Intervention Type: DIETARY_SUPPLEMENT

Supplementation of 1g of fish oil, 3 time a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.

Interventions

Diet + supplementation

Supplementation of 1g of fish oil, 3 time a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.

Intervention Type: DIETARY_SUPPLEMENT

Diet + placebo

Supplementation of 1g of soybean oil, 3 times a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Supplementation of 1g soybean oil, 3 times a day.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)

Exclusion Criteria

• lack of written informed consent;
• age < 18 years old;
• history of gastrointestinal, endocrine, pulmonary, kidney, hepatic, and neuromuscular diseases, as well as HIV-positive;
• pregnant or breast-feeding women;
• previous history of cancer;
• use of steroids, protein supplements, vitamins, multivitamins, or antioxidants.
• Specific medications to PsA and physical activity were required to be stable for the last 3 months to be included in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marcelo M Pinheiro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Scherer D, Leite BF, Morimoto MA, Oliveira TL, Klemz BNC, Freitas RAMS, Pappiani C, Damasceno NRT, Pinheiro MM. Nutritional effect on lipoproteins and their subfractions in patients with Psoriatic Arthritis: a 12-week randomized trial-the DIETA trial. Adv Rheumatol. 2024 Jun 13;64(1):47. doi: 10.1186/s42358-024-00389-5.

Reference Type: DERIVED

PMID: 38872193 (View on PubMed)

Leite BF, Morimoto MA, Gomes CMF, Klemz BNC, Genaro PS, Shivappa N, Hebert JR, Damasceno NRT, Pinheiro MM. Dietetic intervention in psoriatic arthritis: the DIETA trial. Adv Rheumatol. 2022 Apr 6;62(1):12. doi: 10.1186/s42358-022-00243-6.

Reference Type: DERIVED

PMID: 35387686 (View on PubMed)

Other Identifiers

2012/18701-2

Identifier Type: -

Identifier Source: org_study_id