Arthritis, PsoriaticDIETNCT03142503
The DIET Trial - Dietetic Intervention in Psoriatic Arthritis
A study testing Diet + supplementation in people with Arthritis, Psoriatic and Metabolic Syndrome, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Psoriatic, Metabolic Syndrome
- What is being tested?
- Diet + supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 21 Jan 2013to 22 Jun 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)
Who cannot join
- 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
About this study
Official title: Effectiveness of a Dietary Intervention Program on Disease Activity, Metabolism and Oxidative Stress in Patients With Psoriatic Arthritis and Psoriasis Activity: A Clinical, Randomized, Placebo-controlled Trial
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
- Being tested
- Diet + supplementation, Diet + placebo, Placebo
- Keywords
- psoriatic arthritis, psoriasis, body composition, DXA measurements, spondyloarthritis, diet therapy, adipose tissue
- Medical subject headings
- Arthritis, Psoriatic, Metabolic Syndrome, Psoriasis, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 + 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.
PlaceboDietary supplement
Supplementation of 1g soybean oil, 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Soybean supplementation Receives: Dietary Supplement: Placebo |
| Diet + placebo | Active comparator | Soybean supplementation and diet intervention Receives: Dietary Supplement: Diet + placebo |
| Diet + Supplementation | Experimental | Omega 3 and diet intervention Receives: Dietary Supplement: Diet + supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
To evaluate the increase of Minimal Disease Activity (MDA) after intervention
Measured: 12 weeks
Secondary outcomes (10)
Fat Mass
To analyze the decrease of Fat Mass Index (kg/m^2)
Measured: 12 weeks
Lean Mass
To evaluate the increase of Muscle Mass (kg)
Measured: 12 weeks
Waist circumference
To observe the improvement of waist circumference (cm)
Measured: 12 weeks
Body Mass Index
To analyze the improvement of Body Mass Index (kg/m^2)
Measured: 12 weeks
Glycation markers
To analyze the decrease of receptor for advanced glycation end products receptor (RAGE)
Measured: 12 weeks
Anti-inflammatory marker
To analyze the increase of adiponectin
Measured: 12 weeks
Lipidic Peroxidation
To analyze the improvement of malondialdehyde (TBARs)
Measured: 12 weeks
Inflammatory markers
To observe the improvement of LDL fractions
Measured: 12 weeks
Cutaneous activity
To evaluated the reduction in cutaneous activity, evaluated by PASI (Psoriasis Area Severity Index)
Measured: 12 weeks
Articular activity
To evaluate the decrease of articular activity, evaluated by DAS28-CRP (Disease Activity Score-C reactive protein) and DAS28-ESR (Disease Activity Score-Erythrocyte Sedimentation Rate).
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 posted5 May 2017
- Study start21 Jan 2013
- Primary completion16 Mar 2015
- Study completion22 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, PsoriaticStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo M Pinheiro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142503
- Sponsor's protocol ID
- 2012/18701-2
- Acronym
- DIET
- Status last verified
- May 2017
- First submitted
- 6 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
Publications
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.
PubMed 38872193Leite 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.
PubMed 35387686
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dietary Intervention Program on Disease Activity, Metabolism and Oxidative Stress in Patients With Psoriatic Arthritis and Psoriasis Activity: A Clinical, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03142503
- Acronym / sponsor ID
- DIET / 2012/18701-2
- Conditions
- Arthritis, Psoriatic, Metabolic Syndrome
- Keywords
- psoriatic arthritis, psoriasis, body composition, DXA measurements, spondyloarthritis, diet therapy, adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 21 Jan 2013 (actual)
- Primary completion
- 16 Mar 2015 (actual)
- Study completion
- 22 Jun 2015 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoybean supplementation |
| Diet + placebo | Active comparator | Dietary Supplement: Diet + placeboSoybean supplementation and diet intervention |
| Diet + Supplementation | Experimental | Dietary Supplement: Diet + supplementationOmega 3 and diet intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Diet + supplementationSupplementation 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. | Dietary supplement | Diet + Supplementation |
| Diet + placeboSupplementation 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. | Dietary supplement | Diet + placebo |
| PlaceboSupplementation of 1g soybean oil, 3 times a day. | Dietary supplement | Placebo |
Primary outcome
Disease activity
Time frame: 12 weeks
To evaluate the increase of Minimal Disease Activity (MDA) after intervention
10 secondary outcomes
Fat Mass
Time frame: 12 weeks
Lean Mass
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Body Mass Index
Time frame: 12 weeks
Glycation markers
Time frame: 12 weeks
Anti-inflammatory marker
Time frame: 12 weeks
Lipidic Peroxidation
Time frame: 12 weeks
Inflammatory markers
Time frame: 12 weeks
Cutaneous activity
Time frame: 12 weeks
Articular activity
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 5 May 2017.
- Derived from this study: PubMed 38872193Scherer 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.
- Derived from this study: PubMed 35387686Leite 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diet + supplementation in people with Arthritis, Psoriatic and Metabolic Syndrome, run by Federal University of São Paulo.
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 1 inclusion and 7 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Disease activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142503, which also lists 2 linked publications.
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 5 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.