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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Fatty Acid Metabolism Disorder; Lipid Metabolism Disorder
• Interventions: Dietary Supplement: omega-3 polyunsaturated fatty acids; Dietary Supplement: corn oil

• Registration Number: NCT06061510
• Lead Sponsor: Southeast University, China

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-08
• Primary Completion: 2019-08-29
• Study Completion: 2020-01-31
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-23
• Study First Posted: 2023-09-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fish oil group	omega-3 polyunsaturated fatty acids	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.
The placebo group	corn oil	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).

Primary Outcome Measures

Name	Time	Method
Concentration of Serum triglycerides	12 weeks	physiological parameter
Concentration of low-density lipoprotein cholesterol	12 weeks	physiological parameter
height in meters	12 weeks	physiological parameter
Diastolic blood pressure	12 weeks	physiological parameter
Concentration of total cholesterol	12 weeks	physiological parameter
weight in kilograms	12 weeks	physiological parameter
body mass index (BMI)	12 weeks	BMI=weight(kg)/height\^2(m)
waist circumference	12 weeks	physiological parameter
Systolic blood pressure	12 weeks	physiological parameter
Concentration of high-density lipoprotein cholesterol	12 weeks	physiological parameter
hip measurement	12 weeks	physiological parameter

Secondary Outcome Measures

Name	Time	Method
Incidence of diabetes complications	12 weeks	This indicator refers to the proportion of participants experiencing complications from diabetes.
Number of Participants who take drugs	12 weeks	This indicator refers to the number of participants taking medication.
Rate of smoking among participants	12 weeks	This indicator refers to the proportion of participants who smoke.

Trial Locations

Locations (1)

Southeast university; 🇨🇳 Nanjing, Jiangsu, China