Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— RA-Diet  

Official title:

Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291299
• Other study ID #: 227188
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: March 2025

Study information

• Verified date: July 2023
• Source: Attune Health Research, Inc.
• Contact: Natalie Fortune, MS
• Phone: 3106520010
• Email: research.admin[@]attunehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Anti-inflammatory diet
Patients randomized to the intervention group will work with a registered dietitian to create an individualized diet program to help reduce inflammation and Rheumatoid arthritis related symptoms.

Other:
• Control/Standard of Care
Patients randomized to the control group will be following standard of care where their doctor will instruct them to follow a Mediterranean diet and provides them with an instructional sheet.

Locations

Country	Name	City	State
United States	Attune Health Research Inc	Beverly Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Attune Health Research, Inc.	Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (21)

Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584. — View Citation

Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649. — View Citation

Bigaard J, Frederiksen K, Tjonneland A, Thomsen BL, Overvad K, Heitmann BL, Sorensen TI. Waist circumference and body composition in relation to all-cause mortality in middle-aged men and women. Int J Obes (Lond). 2005 Jul;29(7):778-84. doi: 10.1038/sj.ijo.0802976. — View Citation

Camilleri M, Lyle BJ, Madsen KL, Sonnenburg J, Verbeke K, Wu GD. Role for diet in normal gut barrier function: developing guidance within the framework of food-labeling regulations. Am J Physiol Gastrointest Liver Physiol. 2019 Jul 1;317(1):G17-G39. doi: 10.1152/ajpgi.00063.2019. Epub 2019 May 24. — View Citation

Chen YM, Chen HH, Hsieh CW, Hsieh TY, Lan JL, Chen DY. A close association of body cell mass loss with disease activity and disability in Chinese patients with rheumatoid arthritis. Clinics (Sao Paulo). 2011;66(7):1217-22. doi: 10.1590/s1807-59322011000700016. — View Citation

Darlington LG, Ramsey NW, Mansfield JR. Placebo-controlled, blind study of dietary manipulation therapy in rheumatoid arthritis. Lancet. 1986 Feb 1;1(8475):236-8. doi: 10.1016/s0140-6736(86)90774-9. — View Citation

de Carvalho MR, Tebexreni AS, Salles CA, Barros Neto T, Natour J. Oxygen uptake during walking in patients with rheumatoid arthritis--a controlled study. J Rheumatol. 2004 Apr;31(4):655-62. — View Citation

Deyo RA, Katrina Ramsey, Buckley DI, Michaels L, Kobus A, Eckstrom E, Forro V, Morris C. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Pain Med. 2016 Feb;17(2):314-24. doi: 10.1093/pm/pnv046. — View Citation

Gioia C, Lucchino B, Tarsitano MG, Iannuccelli C, Di Franco M. Dietary Habits and Nutrition in Rheumatoid Arthritis: Can Diet Influence Disease Development and Clinical Manifestations? Nutrients. 2020 May 18;12(5):1456. doi: 10.3390/nu12051456. — View Citation

Guerreiro CS, Calado A, Sousa J, Fonseca JE. Diet, Microbiota, and Gut Permeability-The Unknown Triad in Rheumatoid Arthritis. Front Med (Lausanne). 2018 Dec 14;5:349. doi: 10.3389/fmed.2018.00349. eCollection 2018. — View Citation

Khanna S, Jaiswal KS, Gupta B. Managing Rheumatoid Arthritis with Dietary Interventions. Front Nutr. 2017 Nov 8;4:52. doi: 10.3389/fnut.2017.00052. eCollection 2017. — View Citation

Kjeldsen-Kragh J, Haugen M, Borchgrevink CF, Laerum E, Eek M, Mowinkel P, Hovi K, Forre O. Controlled trial of fasting and one-year vegetarian diet in rheumatoid arthritis. Lancet. 1991 Oct 12;338(8772):899-902. doi: 10.1016/0140-6736(91)91770-u. — View Citation

Konijn NP, van Tuyl LH, Bultink IE, Lems WF, Earthman CP, van Bokhorst-de van der Schueren MA. Making the invisible visible: bioelectrical impedance analysis demonstrates unfavourable body composition in rheumatoid arthritis patients in clinical practice. Scand J Rheumatol. 2014;43(4):273-8. doi: 10.3109/03009742.2013.852239. Epub 2014 Feb 7. — View Citation

Leeming ER, Johnson AJ, Spector TD, Le Roy CI. Effect of Diet on the Gut Microbiota: Rethinking Intervention Duration. Nutrients. 2019 Nov 22;11(12):2862. doi: 10.3390/nu11122862. — View Citation

Paolino S, Pacini G, Patane M, Alessandri E, Cattelan F, Goegan F, Pizzorni C, Gotelli E, Cutolo M. Interactions between microbiota, diet/nutrients and immune/inflammatory response in rheumatic diseases: focus on rheumatoid arthritis. Reumatologia. 2019;57(3):151-157. doi: 10.5114/reum.2019.86425. Epub 2019 Jun 28. — View Citation

Shadick NA, Sowell NF, Frits ML, Hoffman SM, Hartz SA, Booth FD, Sweezy M, Rogers PR, Dubin RL, Atkinson JC, Friedman AL, Augusto F, Iannaccone CK, Fossel AH, Quinn G, Cui J, Losina E, Schwartz RC. A randomized controlled trial of an internal family systems-based psychotherapeutic intervention on outcomes in rheumatoid arthritis: a proof-of-concept study. J Rheumatol. 2013 Nov;40(11):1831-41. doi: 10.3899/jrheum.121465. Epub 2013 Aug 15. — View Citation

Subar AF, Kipnis V, Troiano RP, Midthune D, Schoeller DA, Bingham S, Sharbaugh CO, Trabulsi J, Runswick S, Ballard-Barbash R, Sunshine J, Schatzkin A. Using intake biomarkers to evaluate the extent of dietary misreporting in a large sample of adults: the OPEN study. Am J Epidemiol. 2003 Jul 1;158(1):1-13. doi: 10.1093/aje/kwg092. — View Citation

Subar AF, Thompson FE, Kipnis V, Midthune D, Hurwitz P, McNutt S, McIntosh A, Rosenfeld S. Comparative validation of the Block, Willett, and National Cancer Institute food frequency questionnaires : the Eating at America's Table Study. Am J Epidemiol. 2001 Dec 15;154(12):1089-99. doi: 10.1093/aje/154.12.1089. — View Citation

Tajik N, Frech M, Schulz O, Schalter F, Lucas S, Azizov V, Durholz K, Steffen F, Omata Y, Rings A, Bertog M, Rizzo A, Iljazovic A, Basic M, Kleyer A, Culemann S, Kronke G, Luo Y, Uberla K, Gaipl US, Frey B, Strowig T, Sarter K, Bischoff SC, Wirtz S, Canete JD, Ciccia F, Schett G, Zaiss MM. Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis. Nat Commun. 2020 Apr 24;11(1):1995. doi: 10.1038/s41467-020-15831-7. — View Citation

Thompson FE, Subar AF, Brown CC, Smith AF, Sharbaugh CO, Jobe JB, Mittl B, Gibson JT, Ziegler RG. Cognitive research enhances accuracy of food frequency questionnaire reports: results of an experimental validation study. J Am Diet Assoc. 2002 Feb;102(2):212-25. doi: 10.1016/s0002-8223(02)90050-7. — View Citation

Zhong D, Wu C, Zeng X, Wang Q. The role of gut microbiota in the pathogenesis of rheumatic diseases. Clin Rheumatol. 2018 Jan;37(1):25-34. doi: 10.1007/s10067-017-3821-4. Epub 2017 Sep 15. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity	Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission	8 weeks
Primary	Disease Activity	Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission	52 weeks
Secondary	Patient reported outcomes	change in patient reported disease related outcomes measured by Health Assessment Questionaire-Disability Index, where a higher score indicates lower quality of health. A 0 indicates no difficulty in task performance while a score of 3 indicates much difficulty in task performance	8 weeks
Secondary	Patient reported outcomes	change in patient reported disease related outcomes measured by Health Assessment Questionaire-Disability Index, where a higher score indicates lower quality of health. A 0 indicates no difficulty in task performance while a score of 3 indicates much difficulty in task performance	52 weeks
Secondary	Patient reported outcomes	change in patient reported disease related outcomes measured by Physical and Mental Health Summary Score (PROMIS-29) where a score of 0 indicates excellent mental and physical health while a score of 10 indicates poor mental and physical health.	8 weeks
Secondary	Patient reported outcomes	change in patient reported disease related outcomes measured by Physical and Mental Health Summary Score (PROMIS-29) where a score of 0 indicates excellent mental and physical health while a score of 10 indicates poor mental and physical health.	52 weeks
Secondary	Anthropometric measurements	Assess the change in anthropometric measurements by weight	8 weeks
Secondary	Anthropometric measurements	Assess the change in anthropometric measurements by weight	52 weeks
Secondary	Anthropometric measurements	Assess the change in anthropometric measurements by body fat percentage (waist circumference)	8 weeks
Secondary	Anthropometric measurements	Assess the change in anthropometric measurements by body fat percentage (waist circumference)	52 weeks
Secondary	Anthropometric measurements	Assess the change in anthropometric measurements by waist/hip ratio	8 weeks
Secondary	Anthropometric measurements	Assess the change in anthropometric measurements by waist/hip ratio	52 weeks