Clinical trial NCT05291299: Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis
Official title: Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Attune Health Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2022-03-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with RA participating in a dietary intervention compared to those in the control group measured by DAS-28. Other measures to track disease activity will include monitoring number and severity of disease flares and any changes in medications. This will be done by completing a single-blinded randomized controlled trial, parallel in design. The study population will consist of adults diagnosed with Seropositive and Seronegative RA based on the American College of Rheumatology criteria. Participants will have low, moderate, or high disease activity based on DAS-28 where the investigator feels that they can see improvement from a dietary intervention.

Detailed description: Per the Schedule of Assessments, upon enrollment, participants will be required to come in for a total of five on site visits. The first visit, also known as the baseline visit, will require participants to provided informed consent after all eligibility criteria is met. Subsequently, participants' Demographics, Medical History, EULAR/ACR classification, and physicians' assessments will be documented. Participants' vital signs will be checked and a thorough physical exam will also be performed after which safety labs will be drawn in addition to a routine urinalysis. Participants will complete outcome surveys and a food frequency questionnaire. Participants' body composition will be measured. Concomitant medications will be reviewed. Each participant will receive nutrition education from an approved MD or a consultation with an approved RD depending on the group to which they have been randomized. Participants who receive consultations with an RD will have seven follow up visits after the baseline visit.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years.
* Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria.
* Low, moderate, or highly active disease state based on clinical assessment where the investigator feels there is potential to see a difference.
* Able to read and write in English.

Exclusion Criteria:

* Younger than 18 years.
* Unable to attend the 8 weekly nutrition appointment.
* History of documented eating disorders.

Primary outcomes:
measure: Disease Activity
timeFrame: 8 weeks
measure: Disease Activity
timeFrame: 52 weeks
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: 8 weeks
measure: Patient reported outcomes
timeFrame: 52 weeks
measure: Patient reported outcomes
timeFrame: 8 weeks
measure: Patient reported outcomes
timeFrame: 52 weeks
measure: Anthropometric measurements
timeFrame: 8 weeks
measure: Anthropometric measurements
timeFrame: 52 weeks
measure: Anthropometric measurements
timeFrame: 8 weeks
measure: Anthropometric measurements
timeFrame: 52 weeks
measure: Anthropometric measurements
timeFrame: 8 weeks
measure: Anthropometric measurements
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Attune Health Research Inc
state: California
Study officials:
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