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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Concentration of Serum triglycerides
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
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
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: omega-3 polyunsaturated fatty acids (Dietary Supplement)
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).
Intervention: corn oil (Dietary Supplement)
Outcomes
Primary Outcomes
Concentration of Serum triglycerides
Time Frame: 12 weeks
physiological parameter
Concentration of low-density lipoprotein cholesterol
Time Frame: 12 weeks
physiological parameter
height in meters
Time Frame: 12 weeks
physiological parameter
Diastolic blood pressure
Time Frame: 12 weeks
physiological parameter
Concentration of total cholesterol
Time Frame: 12 weeks
physiological parameter
weight in kilograms
Time Frame: 12 weeks
physiological parameter
body mass index (BMI)
Time Frame: 12 weeks
BMI=weight(kg)/height\^2(m)
waist circumference
Time Frame: 12 weeks
physiological parameter
Systolic blood pressure
Time Frame: 12 weeks
physiological parameter
Concentration of high-density lipoprotein cholesterol
Time Frame: 12 weeks
physiological parameter
hip measurement
Time Frame: 12 weeks
physiological parameter
Secondary Outcomes
- Incidence of diabetes complications(12 weeks)
- Number of Participants who take drugs(12 weeks)
- Rate of smoking among participants(12 weeks)
Investigators
Jia-yue Xia
Principal Investigator
The First Affiliated Hospital with Nanjing Medical University