TrialNet 06: Nutritional Intervention to Prevent (NIP) Type 1 Diabetes Pilot Trial

Type 1 diabetes (T1D) is a common childhood disease caused by islet cell autoimmunity. Reports suggest omega-3 fatty acids may decrease the risk of T1D by suppressing the inflammatory immune responses that initiate the process of islet autoimmunity. Various epidemiological studies and observations have concluded that the intake of omega-3 fatty acids is associated with a decreased risk of the development of T1D in children with an increased genetic risk for the disease.

The TrialNet 06 study hypothesized that islet autoimmunity could be prevented in infants, with an increased risk for T1D, through the consumption of DHA, an omega-3 fatty acid. Participants were enrolled during pregnancy or after birth, and randomized into the treatment or control group. During the study, subjects in the treatment group received a vegetarian DHA substance while those in the control group received a placebo. Treatments were administered daily for at least 36 months from the date of birth or the date of randomization. Participants were regularly tested for DHA and inflammatory cytokine levels. Additionally, TrialNet 06 was used as a pilot trial in order to determine the feasibility of a full-scale DHA supplementation study.