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

NCT ID: NCT03708887

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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Hyperglycaemia (Diabetic) Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose group

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

Group Type EXPERIMENTAL

Low dose omega-3 fatty acid supplementation

Intervention Type DRUG

Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year

High dose group

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

Group Type EXPERIMENTAL

High dose omega-3 fatty acid supplementation

Intervention Type DRUG

Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year

Control group

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

Group Type PLACEBO_COMPARATOR

Control drug

Intervention Type DRUG

Matching placebo capsules,3 g/d by mouth for 1 year

Interventions

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Low dose omega-3 fatty acid supplementation

Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year

Intervention Type DRUG

High dose omega-3 fatty acid supplementation

Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year

Intervention Type DRUG

Control drug

Matching placebo capsules,3 g/d by mouth for 1 year

Intervention Type DRUG

Other Intervention Names

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Fish oil supplement Fish oil supplement Placebo drug

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Jingjing Jiao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lanxi Red Cross Hospital

Jinhua, Zhejiang, China

Site Status

Countries

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China

References

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Zhuang P, Wu Y, Yao J, Liu X, Liu H, Wan X, Jia W, Wang T, Zhang Y, Jiao J. Marine n-3 polyunsaturated fatty acids slow sleep impairment progression by regulating central circadian rhythms in type 2 diabetes. Cell Rep Med. 2025 May 20;6(5):102128. doi: 10.1016/j.xcrm.2025.102128. Epub 2025 May 9.

Reference Type DERIVED
PMID: 40347940 (View on PubMed)

Other Identifiers

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RCT-N3

Identifier Type: -

Identifier Source: org_study_id

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