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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
omega-3 polyunsaturated fatty acids
corn oil
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Omega-3 Fatty Acids, Gut Microbiota, lipid Metabolome, glycerophospholipid, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lian Shui People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

fish oil group

The placebo group

Arm Description

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 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2023
Last Updated
October 2, 2023
Sponsor
Southeast University, China
Collaborators
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06061510
Brief Title
Fish Oil-derived Omega-3 Fatty Acids on Gut Microbiota and Lipid Metabolome in Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2019 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Lipid Metabolism Disorder, Fatty Acid Metabolism Disorder
Keywords
Omega-3 Fatty Acids, Gut Microbiota, lipid Metabolome, glycerophospholipid, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was a randomised, double-blind trial.
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fish oil group
Arm Type
Experimental
Arm Description
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.
Arm Title
The placebo group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 polyunsaturated fatty acids
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
corn oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concentration of Serum triglycerides
Description
physiological parameter
Time Frame
12 weeks
Title
Concentration of total cholesterol
Description
physiological parameter
Time Frame
12 weeks
Title
Concentration of low-density lipoprotein cholesterol
Description
physiological parameter
Time Frame
12 weeks
Title
Concentration of high-density lipoprotein cholesterol
Description
physiological parameter
Time Frame
12 weeks
Title
weight in kilograms
Description
physiological parameter
Time Frame
12 weeks
Title
height in meters
Description
physiological parameter
Time Frame
12 weeks
Title
body mass index (BMI)
Description
BMI=weight(kg)/height^2(m)
Time Frame
12 weeks
Title
waist circumference
Description
physiological parameter
Time Frame
12 weeks
Title
hip measurement
Description
physiological parameter
Time Frame
12 weeks
Title
Systolic blood pressure
Description
physiological parameter
Time Frame
12 weeks
Title
Diastolic blood pressure
Description
physiological parameter
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants who take drugs
Description
This indicator refers to the number of participants taking medication.
Time Frame
12 weeks
Title
Incidence of diabetes complications
Description
This indicator refers to the proportion of participants experiencing complications from diabetes.
Time Frame
12 weeks
Title
Rate of smoking among participants
Description
This indicator refers to the proportion of participants who smoke.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lian Shui People's Hospital
City
Lianshui
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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