← Back to Search

Anti-inflammatory Diet for Rheumatoid Arthritis (RA-Diet Trial)

N/A

Recruiting

Research Sponsored by Attune Health Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria

Age greater than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

RA-Diet Trial Summary

This trial is designed to see if there is a difference in disease activity scores for people with RA who participate in a dietary intervention, compared to those who don't. The study population will consist of adults with RA, who will be monitored for disease activity.

Who is the study for?

Adults over 18 with Rheumatoid Arthritis (RA), as diagnosed by a rheumatologist, who have varying levels of disease activity and can potentially benefit from dietary changes. Participants must be able to read and write in English but cannot join if they're under 18, unable to attend weekly nutrition meetings, or have a history of eating disorders.Check my eligibility

What is being tested?

The trial is testing whether an anti-inflammatory diet can reduce disease activity in RA patients compared to standard care. It's a single-blinded study where participants are randomly assigned to the diet group or control group without knowing which one they're in.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include adjustments in digestion or food sensitivities. However, significant adverse effects are not typically expected from such interventions.

RA-Diet Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with RA by a specialist.

Select...

I am older than 18 years.

RA-Diet Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Activity

Secondary outcome measures

Anthropometric measurements

Patient reported outcomes

Side effects data

From 2015 Phase 3 trial • 300 Patients • NCT01606319

63%

Acute uri

61%

Fever

26%

Allergic rhinitis

25%

Otitis media NOS

21%

Cough

11%

Strep sore throat

11%

Vomiting

Headache

Diarrhea

Wheezing

asthma exacerbation

Pneumonia

Simple laceration

100%

80%

60%

40%

20%

Study treatment Arm

Acetaminophen

Ibuprofen

RA-Diet Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (Control Group)Experimental Treatment1 Intervention

Physicians will follow standard of care and instruct participants in the control group to follow a Mediterranean diet higher in vegetables and fruits[19]. Patients will be provided with a handout detailing the basics of the Mediterranean diet. At follow up visits, physicians will ask participants about how they have been eating and if they have been following the guidelines.

Group II: Anti-inflammatory Diet (Intervention Group)Experimental Treatment1 Intervention

An 8-week nutrition program consisting of an individualized elimination diet and systematic food reintroduction implemented and supervised by a Registered Dietitian. Clinical trials have shown some benefit from elimination diets for individuals with autoimmune disease [18]. The specifics of the elimination diet including duration and foods included will be individual and up to the RDs discretion based on the patient's medical and diet history, willingness, current diet, preferences, goals, and ability. The initial diet instruction with a Registered Dietitian will be a one-hour, individual secure video call, with nutrition evaluation/assessment and education on elimination diet protocol. Follow up visits will be approximately 20-30 minutes for the subsequent 7 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Attune Health Research, Inc.Lead Sponsor

5 Previous Clinical Trials

1,614 Total Patients Enrolled

3 Trials studying Rheumatoid Arthritis

26 Patients Enrolled for Rheumatoid Arthritis

Cedars-Sinai Medical CenterOTHER

500 Previous Clinical Trials

164,831 Total Patients Enrolled

1 Trials studying Rheumatoid Arthritis

20 Patients Enrolled for Rheumatoid Arthritis

Media Library

Anti-inflammatory diet Clinical Trial Eligibility Overview. Trial Name: NCT05291299 — N/A

Rheumatoid Arthritis Research Study Groups: Standard of Care (Control Group), Anti-inflammatory Diet (Intervention Group)

Rheumatoid Arthritis Clinical Trial 2023: Anti-inflammatory diet Highlights & Side Effects. Trial Name: NCT05291299 — N/A

Anti-inflammatory diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05291299 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots for participants in this trial?

"Per the information located on clinicaltrials.gov, this trial is presently looking for candidates. It was originally posted to the website on July 5th 2022 and its most recent update arrived three days later."

Answered by AI

What is the current number of participants in this investigation?

"That is correct. The clinicaltrials.gov database confirms that this research project, which was initially published on July 5th 2022, is currently searching for participants. Currently the researchers need to recruit 32 individuals from one medical centre."

Answered by AI