A randomized, controlled trial on the effectiveness of a proprietary marine lipo-peptide formula vs omega-3 on cytokines profile, anxiety, and pain symptoms in patients with fibromyalgia | 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. 8 (2022): August 2022 / Research Articles A randomized, controlled trial on the effectiveness of a proprietary marine lipo-peptide formula vs omega-3 on cytokines profile, anxiety, and pain symptoms in patients with fibromyalgia Authors Reza Rastmanesh The Nutrition Society, London, UK Umberto Solimene WHO-collaborating Center for WHO-cntr forTraditional Medicine & Biotechnology, University of Milano, Milano, Italy Aldo Lorenzetti Senior researcher, Regenera Intl. Aging Intervention Francesco Marotta ReGenera R&D International for Aging Intervention, Milano, Italy HE Fang Department of Nutrition and Food hygiene, West China School of Public Health and West China Fourth Hospital, Sichuan University, Sichuan China Cristiana Aperio Senior researcher, Regenera Intl. Aging Intervention Nevenka Anzulovic Senior researcher, Regenera Intl. Aging Intervention Giuseppe Cervi ReGenera R&D International for Aging Intervention, Italy Nicola Zerbinati Department of Medicine and Surgery, University of Insubria, Varese, Italy. DOI: https://doi.org/10.31989/ffhd.v12i8.954 Abstract Objective: The aim of the present study in an RCT manner (physicians and patients) a novel lipo-peptide marine compound, LD-1227, on physical-, emotional- and functional-related symptomatic complaints in fibromyalgia patients as well as inflammatory cytokines profile and gene expression while using omega-3 as a control group. Methods: The following questionnaire-based or clinical evaluation-based parameters were evaluated: widespread pain index [WPI] patient global impression of change, total tender points [TTP], fibromyalgia impact questionnaire, Beck depression inventory, fatigue severity ratings, cognitive symptom severity, symptom severity score [SSS] and weekly pain intensity ratings. Additional biochemical and gene expression analysis of cytokines (IL6, TNF-α, IL-1β, MCP-1, IL-8, IL-13, IL-1α, and GM-CSF) was performed as well. Data were analyzed with either a paired t-test or the Wilcoxon signed rank test depending on the parametric or non-parametric distribution. Results: Comparing the data from before and after treatment for Group B indicated a statistically significant reduction (p=0.05) in TTP, WPI score, and SSS score. These data suggest a positive effect of a 3-month treatment with the LD-1227 but not omega-3 treatment on Fibromyalgia pain and related anxiety/depressive symptoms. Inspections of HRV and Cytokines found a statistically significant improvement after LD1227 treatment. Unlike the group supplemented with omega-3, the treatment with LD-1227 brought about a decrease in WPI and weekly pain intensity symptoms for the majority of participants. The pre-and post-treatment data for Group B indicated a statistically significant reduction (p=0.05) in TPC, WPI, and SSS scores. No adverse events were reported. Conclusion: These results provide the first indications that the LD-1227 treatment has a statistically significant effect on the recognized fibromyalgia diagnosis metrics of WPI, TTP, and SSS as well on inflammatory markers and parasympathetic balance. Keywords: fibromyalgia, marine compound, lipopeptide, cytokines, anxiety, pain, LD-1227. Downloads [Abstract] [Full Article] Published 2022-08-26 Issue Vol. 12 No. 8 (2022): August 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. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged. By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained. About the Journal      Editing Services      Graphical Abstract      Journal Insights        Submissions        Editorial Team       Privacy Statement        Contact        Current        Archives   Open Journal Systems Hosting and Support by: OpenJournalSystems.com