NCT03708887

The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients

Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A double-blind and placebo-controlled study is conducted in the current human study. The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.

Detailed description

Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.

Conditions

• Hyperglycaemia (Diabetic)
• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	Low dose omega-3 fatty acid supplementation	Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year
DRUG	High dose omega-3 fatty acid supplementation	Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
DRUG	Control drug	Matching placebo capsules,3 g/d by mouth for 1 year

Timeline

• Start date: 2020-10-10
• Primary completion: 2022-01-02
• Completion: 2022-02-28
• First posted: 2018-10-17
• Last updated: 2024-07-12

Locations

1 site across 1 country: China