NCT03142503

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

April 6, 2017

Last Update Submit

May 4, 2017

Conditions

Arthritis, PsoriaticMetabolic Syndrome

Keywords

psoriatic arthritispsoriasisbody compositionDXA measurementsspondyloarthritisdiet therapyadipose tissue

Outcome Measures

Primary Outcomes (1)

  • Disease activity

    To evaluate the increase of Minimal Disease Activity (MDA) after intervention

    12 weeks

Secondary Outcomes (10)

  • Fat Mass

    12 weeks

  • Lean Mass

    12 weeks

  • Waist circumference

    12 weeks

  • Body Mass Index

    12 weeks

  • Glycation markers

    12 weeks

  • +5 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Soybean supplementation

Dietary Supplement: Placebo

Diet + placebo

ACTIVE COMPARATOR

Soybean supplementation and diet intervention

Dietary Supplement: Diet + placebo

Diet + Supplementation

EXPERIMENTAL

Omega 3 and diet intervention

Dietary Supplement: Diet + supplementation

Interventions

Diet + supplementationDIETARY_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.

Diet + Supplementation
Diet + placeboDIETARY_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 + placebo
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 38872193DERIVED

  • 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.

    PMID: 35387686DERIVED

MeSH Terms

Conditions

Arthritis, PsoriaticMetabolic SyndromePsoriasisSpondylarthritis

Interventions

DietDietary Supplements

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2017

First Posted

May 5, 2017

Study Start

January 21, 2013

Primary Completion

March 16, 2015

Study Completion

June 22, 2015

Last Updated

May 5, 2017

Record last verified: 2017-05