Rheumatoid ArthritisDAIARNCT05336513
The Effect of an Anti-inflammatory Diet in Patients With Rheumatoid Arthritis
A study testing Diet anti-inflammatory in people with Rheumatoid Arthritis, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Diet anti-inflammatory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2021to 20 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years;
- Presence of active disease, (DAS28≥ 2.6), under adequate control and medication.
- Able to sign informed consent
Who cannot join
- Any type of psychological deficiency, dementia or eating disorder;
- Presence of food allergies and / or intolerances;
- Be vegetarian or use Phytotherapy or other supplements (namely, pre and probiotics);
- Use of antibiotics im the last 6 months;
- Have had previous nutritional monitoring or change in eating habits in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Anti-inflammatory Diet on Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis - Parallel Controlled Randomized Clinical Trial
Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option.
The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL.
Read more
Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention.
As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.
Read the detailed description
The main objective of this trial is to check the effect of an DAI, compared to a DC, on reducing AD and improving QL.
As secondary objectives, it is intended to investigate the relationship of DAI with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a DC.
This study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation.
These results are intended to further contribute to clinical decision making and better evidence-based treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Diet Control, Diet anti-inflammatory
- Keywords
- Anti-inflammatory diet, Disease activity, Quality of life, Rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet ControlOther
Diet following mediterranean principles, for 15 weeks
Diet anti-inflammatoryOther
Diet combining food items with anti-inflammatory potential, following the principles described in Rondanelli, Clinical Nutrition, 2021 Mar;40(3):661-689. doi: 10.1016/j.clnu.2020.08.020.
| Study group | Role | What they receive |
|---|---|---|
| Diet Control | Other | Diet Control (DC): nutritional education and adherence monitoring. DC will be based on the Portuguese "Nova Roda dos Alimentos" following the principles of the Mediterranean diet. Receives: Other: Diet Control |
| Diet Anti-inflammatory | Experimental | Diet Anti-inflammatory (DAI): nutritional education and adherence monitoring. The DAI dietary intervention will be based on combining individual food items described as potential anti-inflammatory mitigators. Receives: Other: Diet anti-inflammatory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in disease activity
Difference between the intervention and control group in the changes in Disease Activity (using DAS28 score: greater than 2,6 implies active disease), from baseline to the end of follow-up
Measured: 15 weeks
Changes in Quality of Life
Difference between the intervention and control group in changes in Quality of Life (Health Assessment Questionnaire (HAQ): scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability), from baseline to the end of follow-up
Measured: 15 weeks
Secondary outcomes (7)
Changes in C-Reactive Protein (CRP)
Difference between the intervention and control group in changes in C-Reactive Protein (CRP) measured in mg/L, from baseline to the end of follow-up
Measured: 15 weeks
Changes in Erythrocyte Sedimentation Rate (ESR)
Difference between the intervention and control group in changes in Erythrocyte Sedimentation Rate (ESR) measured in mm/h, from baseline to the end of follow-up
Measured: 15 weeks
Changes in Rheumatoid Factor (RF)
Difference between the intervention and control group changes in Rheumatoid Factor (RF) measured in IU/mL, from baseline to the end of follow-up
Measured: 15 weeks
Changes in Gut microbiota
Difference between the intervention and control group in the change of gut microbiota from baseline to the end of follow-up.
Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
Measured: 15 weeks
Changes in weight
Difference between the intervention and control group changes in weight, measured in Kg, from baseline to the end of follow-up
Measured: 15 weeks
Changes in Body Mass Index (BMI)
Difference between the intervention and control group changes in BMI, calculated using weight and height, presented in kg/m2: underweight < 18,5; normoweight 18,6-24,9; overweight 25-29,9; obese >30, from baseline to the end of follow-up
Measured: 15 weeks
Changes in waist circumference perimeter
Difference between the intervention and control group changes in waist circumference perimeter, measured in cm, from baseline to the end of follow-up
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Particular do Algarve - HPA Saúde
- Responsible party
- Sponsor
- Investigators
- Ana Faria, PhD, Principal investigator, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336513
- Sponsor's protocol ID
- DAIAR
- Acronym
- DAIAR
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Anti-inflammatory Diet on Disease Activity and Quality of Life in Patients With Rheumatoid Arthritis - Parallel Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05336513
- Acronym / sponsor ID
- DAIAR / DAIAR
- Conditions
- Rheumatoid Arthritis
- Keywords
- Anti-inflammatory diet, Disease activity, Quality of life, Rheumatoid arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Hospital Particular do Algarve - HPA Saúde
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 20 Apr 2022 (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.
Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option.
The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL.
Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention.
As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.
Detailed description
The main objective of this trial is to check the effect of an DAI, compared to a DC, on reducing AD and improving QL.
As secondary objectives, it is intended to investigate the relationship of DAI with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a DC.
This study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation.
These results are intended to further contribute to clinical decision making and better evidence-based treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Control | Other | Other: Diet ControlDiet Control (DC): nutritional education and adherence monitoring. DC will be based on the Portuguese "Nova Roda dos Alimentos" following the principles of the Mediterranean diet. |
| Diet Anti-inflammatory | Experimental | Other: Diet anti-inflammatoryDiet Anti-inflammatory (DAI): nutritional education and adherence monitoring. The DAI dietary intervention will be based on combining individual food items described as potential anti-inflammatory mitigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years;
- Presence of active disease, (DAS28≥ 2.6), under adequate control and medication.
- Able to sign informed consent
Key exclusion criteria (5 listed)
- Any type of psychological deficiency, dementia or eating disorder;
- Presence of food allergies and / or intolerances;
- Be vegetarian or use Phytotherapy or other supplements (namely, pre and probiotics);
- Use of antibiotics im the last 6 months;
- Have had previous nutritional monitoring or change in eating habits in the last 6 months.
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 ControlDiet following mediterranean principles, for 15 weeks | Other | Diet Control |
| Diet anti-inflammatoryDiet combining food items with anti-inflammatory potential, following the principles described in Rondanelli, Clinical Nutrition, 2021 Mar;40(3):661-689. doi: 10.1016/j.clnu.2020.08.020. | Other | Diet Anti-inflammatory |
Primary outcome
Changes in disease activity
Time frame: 15 weeks
Difference between the intervention and control group in the changes in Disease Activity (using DAS28 score: greater than 2,6 implies active disease), from baseline to the end of follow-up
Changes in Quality of Life
Time frame: 15 weeks
Difference between the intervention and control group in changes in Quality of Life (Health Assessment Questionnaire (HAQ): scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability), from baseline to the end of follow-up
7 secondary outcomes
Changes in C-Reactive Protein (CRP)
Time frame: 15 weeks
Changes in Erythrocyte Sedimentation Rate (ESR)
Time frame: 15 weeks
Changes in Rheumatoid Factor (RF)
Time frame: 15 weeks
Changes in Gut microbiota
Time frame: 15 weeks
Changes in weight
Time frame: 15 weeks
Changes in Body Mass Index (BMI)
Time frame: 15 weeks
Changes in waist circumference perimeter
Time frame: 15 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 20 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ana Faria, PhD principal investigator
Universidade Nova de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet anti-inflammatory in people with Rheumatoid Arthritis, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 3 inclusion and 5 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Changes in disease activity (time frame: 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.