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

NCT06061510 | Completed

• 1 other identifier: NO. 2019710-6
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• Number of Participants who take drugs

  12 weeks

• Incidence of diabetes complications

  12 weeks

• Rate of smoking among participants

  12 weeks

Study Arms (2)

fish oil group

EXPERIMENTAL

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

The placebo group

PLACEBO COMPARATOR

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

Interventions

omega-3 polyunsaturated fatty acids DIETARY_SUPPLEMENT

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.

fish oil group

corn oil DIETARY_SUPPLEMENT

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.

The placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

Southeast university

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Lipid Metabolism Disorders

Interventions

Docosahexaenoic Acids; Corn Oil

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was a randomised, double-blind trial.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 29, 2023
• Study Start: June 8, 2019
• Primary Completion: August 29, 2019
• Study Completion: January 31, 2020
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)