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

Sponsor

Southeast University, China (Other)

Overall Status

Completed

CT.gov ID

NCT06061510

Collaborator

The First Affiliated Hospital with Nanjing Medical University (Other)

110

Enrollment

Location

Arms

7.8

Actual Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Lipid Metabolism Disorder Fatty Acid Metabolism Disorder	Dietary Supplement: omega-3 polyunsaturated fatty acids Dietary Supplement: corn oil	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study was a randomised, double-blind trial.The study was a randomised, double-blind trial.

Masking:

Double (Participant, Investigator)

Masking Description:

The study was a randomised, double-blind trial, and neither the subjects nor the research workers knew the exact subgroups or the progress of the treatment

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 8, 2019

Actual Primary Completion Date :

Aug 29, 2019

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fish oil group 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 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.
Placebo Comparator: The placebo group 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 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.

Arm

Intervention/Treatment

Experimental: fish oil group

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

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.

Placebo Comparator: The placebo group

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

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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