Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus

Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-Controlled Clinical Trial

The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.

The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.

Inclusion Criteria:

• Patients with type 2 diabetes have been diagnosed;
• Male or female aged 18-70 years;
• After listening to the project presentation, voluntarily participate in the study and sign an informed consent form.

Exclusion Criteria:

• Pregnant or lactating women;
• Poorly controlled diabetes, i.e. HbA1c>9%；
• Have taken omega-3 PUFAs-related supplements in the past six months；
• Taking lipid-lowering drugs or other drugs that affect blood lipid metabolism；
• Patients with severe diabetic complications, severe hypertension, combined with
• diseases of the heart, brain, liver, kidney, thyroid and hematopoietic system, psychosis；
• Patients with severe immune system disorders；
• Have special diets: vegetarians, weight managers, ketogenic test takers, etc；
• The attending physician deems the participant unsuitable