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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06061510
• Other study ID #: NO. 2019710-6
• Status: Completed
• Phase: N/A
• Start date: June 8, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: November 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 31, 2020
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Southeast university	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Serum triglycerides	physiological parameter	12 weeks
Primary	Concentration of total cholesterol	physiological parameter	12 weeks
Primary	Concentration of low-density lipoprotein cholesterol	physiological parameter	12 weeks
Primary	Concentration of high-density lipoprotein cholesterol	physiological parameter	12 weeks
Primary	weight in kilograms	physiological parameter	12 weeks
Primary	height in meters	physiological parameter	12 weeks
Primary	body mass index (BMI)	BMI=weight(kg)/height^2(m)	12 weeks
Primary	waist circumference	physiological parameter	12 weeks
Primary	hip measurement	physiological parameter	12 weeks
Primary	Systolic blood pressure	physiological parameter	12 weeks
Primary	Diastolic blood pressure	physiological parameter	12 weeks
Secondary	Number of Participants who take drugs	This indicator refers to the number of participants taking medication.	12 weeks
Secondary	Incidence of diabetes complications	This indicator refers to the proportion of participants experiencing complications from diabetes.	12 weeks
Secondary	Rate of smoking among participants	This indicator refers to the proportion of participants who smoke.	12 weeks