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


  • 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.




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.





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