Adjuvant benefit of a peptide-rich marine biology formula (LD- 1227) in rheumatoid arthritis: a randomized, double-blind, controlled study | Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Skip to main content Skip to main navigation menu Skip to site footer Open Menu Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Home Food Science Publisher Functional Food Center Current Archives About About the Journal Aims and Scope Contact Editing Services Editorial Team Express Peer Review Graphical Abstract Journal Insights Privacy Statement Submissions Announcements Search Search Register Login Home / Archives / Vol. 12 No. 9 (2022): September 2022 / Research Articles Adjuvant benefit of a peptide-rich marine biology formula (LD- 1227) in rheumatoid arthritis: a randomized, double-blind, controlled study Authors Lorenzetti Aldo Senior researcher, Regenera Intl. Aging Intervention Solimene Umberto WHO-collaborating Center for WHO-cntr forTraditional Medicine & Biotechnology, University of Milano, Milano, Italy Rastmanesh Reza The Nutrition Society, London, UK Francesco Marotta n/a Fang HE Department of Nutrition and Food hygiene, West China School of Public Health and West China Fourth Hospital, Sichuan University, Sichuan China Rasulova S Aperio Cristiana Senior researcher, Regenera Intl. Aging Intervention Anzulovic Nevenka Researcher, Regenera Intl. Aging Intervention. Zerbinati Nicola Department of Medicine and Surgery, University of Insubria, Varese, Italy. DOI: https://doi.org/10.31989/ffhd.v12i9.960 Abstract Introduction. There is a growing interest on non-chemical therapies among patients suffering from rheumatoid arthritis (RA), although safety, efficacy and properly designed studies are often lacking.  Objective. The aim of the present investigation was to explore the clinical effectiveness of a marine nutraceutical, LD-1227, endowed by fine molecular biology studies, in the management of RA.  Methods. The study design was a 12-week, randomized, double-blind study involving forty patients with stable long-standing RA who were randomized to receive either LD-1227 (n = 20) or Omega-3 (n = 20) on top of their established maintenance therapy.  Results. At study recruitment and after 12 weeks of treatment, their Health Assessment Questionnaire (HAQ), erythrocyte sedimentation rate (ESR), visual analogue scale (VAS), and Disease Activity Score (DAS) 28, anxiety and depression analysis, C-reactive protein (CRP) levels, CXCL1, several pro-inflammatory interleukins levels and related gene expression, were compared between the two groups. Primary end point was the proportion of patients with response at weeks 12 as from the 20 % to 50% improvement criteria of the American College of Rheumatology (ACR20). At 12 weeks, ACR20 beneficial response was 81.0 % in LD-1227 group and 44 % in omega-3 group, (p< 0.01). The superiority of LD-1227 appeared also when considering the ACR50 response at 12 weeks (62% in LD-1227 group as compared to 31 % in omega-3 group, p< 0.01). The LD-1227-treated group displayed a significant improvement of VAS scale, HAQ score, morning stiffness and tender points (p < 0.01 vs control and p < 0.05 vs omega-3, respectively). From the biochemical viewpoint, patients in the LD-1227 group showed a lower level of CRP, IL-6, TNF-α, IL-1β, CXCL1, IFNγ, IL-15 and IP-10 and significant downregulation of related gene expressions. Unlike what observed in LD-1227 group, in the omega-3 group, CRP and DAS28 did not reach statistical difference. A substantial reduction of extra pain killer use was noted under LD-1227 treatment.  Conclusion. One can conclude that LD-1227 may play a significant role on the management of RA and with a specrum and mechanisms of actions distinct from the canonical omega-3 while being devoid of any side effect or tolerability issues. Keywords: rheumatoid arthritis, cytokines, omega-3, marine peptides, inflammation, pain, gene expression Downloads [Abstract] [Full Article] Published 2022-09-07 Issue Vol. 12 No. 9 (2022): September 2022 Section Research Articles License Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License. This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. 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