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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Lipid Metabolism Disorder, Fatty Acid Metabolism Disorder

Intervention / Treatment
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* Dietary Supplement: omega-3 polyunsaturated fatty acids
* Dietary Supplement: corn oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was a randomised, double-blind trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fish oil group<br>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. | Dietary Supplement: omega-3 polyunsaturated fatty acids<br>* Participants in the intervention group took fish oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.<br>|
| Placebo Comparator: The placebo group<br>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). | Dietary Supplement: corn oil<br>* Participants in the placebo group took corn oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who take drugs | This indicator refers to the number of participants taking medication. | 12 weeks | 
| Incidence of diabetes complications | This indicator refers to the proportion of participants experiencing complications from diabetes. | 12 weeks | 
| Rate of smoking among participants | This indicator refers to the proportion of participants who smoke. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 Fatty Acids, Gut Microbiota, lipid Metabolome, glycerophospholipid, Type 2 Diabetes Mellitus