Southeast university
Nanjing, Jiangsu, 210000, China
NCT Number: NCT06061510
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
BMI=weight(kg)/height^2(m)
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
physiological parameter
Time frame: 12 weeks
This indicator refers to the number of participants taking medication.
Time frame: 12 weeks
This indicator refers to the proportion of participants experiencing complications from diabetes.
Time frame: 12 weeks
This indicator refers to the proportion of participants who smoke.
Southeast University, China
Other
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
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