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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Lipid Metabolism Disorder; Fatty Acid Metabolism Disorder
• Intervention / Treatment: Dietary supplement: omega-3 polyunsaturated fatty acids; Dietary supplement: corn oil

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Southeast university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intestinal flora	Determination of faecal flora composition	12 weeks
lipidomics	Determination of lipid metabolites in serum	12 weeks

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2019
• Primary Completion (Actual): August 29, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 23, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Gut Microbiota; Type 2 Diabetes Mellitus; Omega-3 Fatty Acids; lipid Metabolome; glycerophospholipid
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: NO. 2019710-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No