We spoke with Camillo Ricordi, MD, Director of the Diabetes Research Institute (DRI) about the Poseidon Trial that is actively recruiting participants.
Criteria for Participation
DRI is seeking 56 people – 28 adults, and 28 children – to participate in the trial. Each person needs to be between the ages of 6 and 65 years and has been diagnosed with type 1 diabetes within the last 10 years. In addition, your C-peptides will need to be ≥0.2 ng/mL in order to be eligible.
You can live anywhere in the US as long as you are willing to travel to Miami every 4 months. No monetary compensation or reimbursement will be provided for study participation.
The Omega-3 and Vitamin D will be provided at no cost. The dose will depend on laboratory results obtained during the study and will be adjusted as needed.
The study will last for 2 years. Your participation is voluntary; you may choose to leave the study at any time.
Trial Basis
The human body can make most types of fats it needs from other fats or raw materials. The body can make the polyunsaturated fat omega-6 (n-6) but it can not make omega-3 (n-3). Omega-3 fatty acids must come from foods such as fish, vegetable oils, nuts (especially walnuts), flax seeds, flaxseed oil, and leafy vegetables.
Inflammation
Cell membranes require unsaturated fatty acids to maintain structure and function and omega-3 fatty acids reduce inflammatory cytokines and inflammatory prostaglandins.
Urban Omega-3 Intake Down
Just 100 years ago, consumption of n-6 to n-3 fatty acids in the diet was at a 1:1 ratio. In 1999, the ratio was reported to be approximately 30:1. Today, fish is an expensive luxury in most diets and other sources of protein are relatively much cheaper.
In addition, because of warnings to eliminate fish during pregnancy, the ratio is likely even greater during pregnancy. Without omega-3 in your diet during this critical time of fetal development, the body increases production of inflammation-producing n-6 fatty acids and this may be contributing to the increase in the number of cases of T1D diagnosed each year.
Norwegian Fishing Village Experience
Observations have been made that children who have received omega-3 fatty acid supplementation have a lower risk of T1D.
Children born to women from Norwegian fishing villages had a significantly decreased risk of getting diabetes compared with the children of women who lived in cities away from the coast.
In a larger and more recent study, Stene and colleagues in Norway found that supplementation with cod liver oil during the first year of life was associated with a significantly lower risk of T1D before age 15. It now appears that the protective effect may occur during pregnancy or during infancy or both.
DRI Impetus
“My impetus for starting this study is to determine if modulating inflammation and immunity could halt, or at least delay, the progression of type 1 diabetes. Inflammation may be one of the triggers for autoimmunity that leads to the onset of the disease, but also has an effect on insulin resistance and, therefore, islet dysfunction,” said Camillo Ricordi, M.D., study sponsor and Director of the Diabetes Research Institute at the Miller School of Medicine. “Results from our recent case studies examining the role of omega-3/vitamin D in preserving beta cell function in three pediatric subjects with type 1 diabetes warrant further investigation of this potential therapeutic strategy,” continued Dr. Ricordi, referring to his recent findings in collaboration with Italian centers in Rome and Novara, including those published in European Review for Medical and Pharmacological Sciences.
Sign up for Trial
Click here to apply to participate in the Poseidon Clinical Trial.
