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

Zhejiang University

Status: Completed

Conditions: Hyperlipidemias; Hyperglycaemia (Diabetic)

Treatments: Drug: High dose omega-3 fatty acid supplementation; Drug: Low dose omega-3 fatty acid supplementation; Drug: Control drug

Study type: Interventional

Funder types: Other

Identifiers

NCT03708887

RCT-N3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 415 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
• BMI≥28 for obese groups;
• Aged between 40 and 75 years.

Exclusion criteria

• Type 1 diabetes;
• Cardiovascular disease;
• Cancer;
• Liver or kidney disease;
• Premenopausal women, pregnancy or lactation;
• Allergy to fish;
• Have participated in other clinical trials in the last three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

415 participants in 3 patient groups, including a placebo group

Low dose group

Experimental group

Description:

Low-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year.

Treatment:

Drug: Low dose omega-3 fatty acid supplementation

High dose group

Experimental group

Description:

High-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year.

Treatment:

Drug: High dose omega-3 fatty acid supplementation

Control group

Placebo Comparator group

Description:

Control drug, matching placebo capsules, 3 grams per day for 1 year.

Treatment:

Drug: Control drug