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

Southeast University, China

Status: Completed

Conditions: Lipid Metabolism Disorder; Type 2 Diabetes Mellitus; Fatty Acid Metabolism Disorder

Treatments: Dietary Supplement: omega-3 polyunsaturated fatty acids; Dietary Supplement: corn oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06061510

NO. 2019710-6

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

fish oil group

Experimental group

Description:

Fish oil supplement capsules contained omega-3 polyunsaturated fatty acids supplied by Royal DSM Group, the Netherlands. Each 100 grams of fish oil capsules contains mainly 36.86 grams of EPA, 17.47 grams of DHA and other types of fatty acids.

Treatment:

Dietary Supplement: omega-3 polyunsaturated fatty acids

The placebo group

Placebo Comparator group

Description:

The placebo for fish oil contained corn oil (Each 100 grams of corn oil contained 45.64 grams of linoleic acid, 25.62 grams of oleic acid, 17.0 grams of palmitic acid, and other fatty acids).

Treatment:

Dietary Supplement: corn oil