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Completed

NCT Number: NCT06061510

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southeast university

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Concentration of Serum triglycerides

    Time frame: 12 weeks

    physiological parameter

  2. Concentration of total cholesterol

    Time frame: 12 weeks

    physiological parameter

  3. Concentration of low-density lipoprotein cholesterol

    Time frame: 12 weeks

    physiological parameter

  4. Concentration of high-density lipoprotein cholesterol

    Time frame: 12 weeks

    physiological parameter

  5. weight in kilograms

    Time frame: 12 weeks

    physiological parameter

  6. height in meters

    Time frame: 12 weeks

    physiological parameter

  7. body mass index (BMI)

    Time frame: 12 weeks

    BMI=weight(kg)/height^2(m)

  8. waist circumference

    Time frame: 12 weeks

    physiological parameter

  9. hip measurement

    Time frame: 12 weeks

    physiological parameter

  10. Systolic blood pressure

    Time frame: 12 weeks

    physiological parameter

  11. Diastolic blood pressure

    Time frame: 12 weeks

    physiological parameter

Secondary outcomes

  1. Number of Participants who take drugs

    Time frame: 12 weeks

    This indicator refers to the number of participants taking medication.

  2. Incidence of diabetes complications

    Time frame: 12 weeks

    This indicator refers to the proportion of participants experiencing complications from diabetes.

  3. Rate of smoking among participants

    Time frame: 12 weeks

    This indicator refers to the proportion of participants who smoke.

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 29, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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